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口 罩加州订单没有取消 |

比亚迪的口罩,薛定谔的10亿美元

随着NIOSH否决比亚迪口罩申请消息上热搜,比亚迪又成了汽车界的头条。

美国加州10亿美元的订单给到比亚迪,如今却面临“搁浅”。

一方面比亚迪是“老老实实”给美国做口罩,还打了个“对折”,以显诚意;另一方面比亚迪与加 州州政府订单合同都签了,都生产完了,NIOSH认证却迟迟不能到位,眼看这笔巨额交易要飞。

那比亚迪这次是不是真的被美国“白嫖”了?

01

价值10亿美元口罩订单要告吹

今日,据华尔街日报报道,NIOSH否决了比亚迪N95口罩审批申请,加州政府向比亚迪订购 的价值10亿美元(78亿港元)口罩交易可能告吹。

文章称,NIOSH周三发布声明称,否决比亚迪口罩审批申请的具体原因是保密信息,但早些时 候,对比亚迪中国工程现场评估结果是“不可接受”。NIOSH还称:

“对提交给NIOSH的口罩设计、生产和质检文 件的审查结果令人担忧。”

NIOSH还表示,在比亚迪解决了口罩的不足后,比亚迪可重新提交N95口罩申请,重新审批 将加快进行。










消息一出,舆论哗然。比亚迪知情人士立刻出来“辟谣”,否决许可申请的新闻是假消息。

知情人士表示:

首先,NIOSH并未否决N95口罩的许可申请,比亚迪还要继续补充资料;其次,国内部分媒体及机构,对美国NIOSH的行政处理流程一知半解;最后,预计再次提报的时间为5月底或6月初。

有人觉得,知情人士说的“继续补充材料”有些“隐晦”。

根据华尔街日报中文网今日报道,比亚迪北美分公司的高级通讯总监Frank Girardot表示,首次尝试监管审批申请遭到否决是文书问题,并且,比亚迪已经通过NIOSH认证中口罩检测部分。但是报道中NIOSH明确表明还有 现场评估没有通过的问题,若企业约30%的口罩申请未获批准,一家生产商初次申请遭拒的比率可能会更高。

现在,由于没有通过NIOSH认证,加州的合同宣布延长,比亚迪已经退还了2.475亿美 元。而加州政府和比亚迪签了一份新合同,其中规定:如果比亚迪口罩没能在5月31日之前获得NIOSH认证的话,还得再交2.475亿美元。

对于比亚迪的各种猜测不绝于耳,有人猜测是比亚迪受到了“不公平的待遇”,也有人质疑比亚迪 做口罩本身就是“半路出家”,此前出口曾遇挫,对熔喷布来源“三缄其口”。

02

比亚迪的“滑铁卢”

若果真认证没通过,对比亚迪来说,退回5亿美元定金是今年利润的一大损失。

按单季度,比亚迪已经连续3个季度亏损。比亚迪2020年第一季度营收为196.79亿,同 比下滑35%,净利润1.13亿,同比下滑85%,亏损主要原因是政府补助的大幅下降。

2019年三季度比亚迪扣非后净利润为-1.53亿元,四季度扣非后净利润为-3.57亿 元。


而比亚迪2019年的业绩也不尽人意。比亚迪2019年营收为1277.39亿,同比下降 1.78%,净利润为16.14亿元,同比下降41.93%。

比亚迪利润的下降或许是在意料之中。

从销量和营收看,过去的几年,比亚迪汽车业务业绩出现大量下滑,而二次充电电池及光伏业务业 绩不稳定,手机部件及组装业务毛利率偏低、竞争壁垒不高;更重要是,过去,政府补贴为比亚迪贡献了很多利润,如今补贴退坡并且基本要结束,这对于比亚迪来 说影响很大。比亚迪在年报中也表示,2019年利润下滑主要系行业及政策变化及研发费用上升影响所致。

比亚迪曾被誉为国产新能源汽车“老大”,汽车业务一直是比亚迪的“重头戏”,不过2019 年,汽车业务占总营收已经不到一半,新能源汽车业务营收同比下降 23.42%,可以说汽车业务已经不是给比亚迪贡献利润的“最大功臣” 。

汽车业务下滑主要原因是补贴退坡。2017年,比亚迪的补贴为12.76亿,占净利润的 31.38%;2018年,补贴金额为20.73亿,占比营业外利润达到47%,占了净利润达到74.57%;然而到了2019年,补贴降到了14.83 亿元,同比下滑28.46%。

据媒体,最近比亚迪推出了新车“汉”EV,预估售价在34—43万之间,与蔚来、特斯拉相 比,价格不具备很大优势,目前在欧洲等国已推出,国内市场反响怎样目前还有待观察。


面对主营业务营收下降,特斯拉等对手建厂、降价的动作不断,比亚迪在加速转变策略,加大研发 投入。

2019年,比亚迪的研发费用增长了6.4亿,补贴和研发“一增一减”,颇有点接受挑战、重 新“启航”的意思。

但现实来看,比亚迪的转型还需要一段时间。

2019年二次充电电池及光伏业务虽然营收105.06亿,同比上涨了17.38%,但是业 绩不算稳定。2018年二次充电电池及光伏业务的收入同比仅上升2.09%,仅占毛利4%,并且连续第二年同比下滑。

至于手机部件及组装业务,虽然起步早,但是相比汽车业务毛利率21.88%,手机业务毛利率 只有9.35%。并且,做手机部件及组装业务竞争对手诸多,比如“超级工厂”富士康。

其他业务尝试中,“云轨”项目也随着几个城市的停工而“搁浅”,比亚迪“老大哥”的位置看来 要不保了。

03

美国“白嫖”了比亚迪?

比亚迪业绩不佳,口罩的“烦心事”又添堵。

有观点认为美国是“白嫖”了比亚迪,甚至由于美国口罩产能已经到了1000万每日,不需要中 国生产口罩,加州政府是故意给比亚迪“挖坑”。

事实上,加州与比亚迪的关系“非同一般”。比亚迪在加州有设厂,此前解决了加州的部分就业, 并且加州州长加文·纽索姆公开表态,只有比亚迪能提供如此大量的口罩,并且3.3美元一个,价格很合适,所以才签约,把4.95亿打给了比 亚迪。

纽索姆认为是一个“不错的交易”,王传福也觉得要表表诚意,最后放弃了一大部分利润,10亿 的订单以约5亿成交。但很多美国人却觉得,这就是不支持“国货(比如霍尼韦尔)”的体现。

或许是一些美国政客影响,“骚操作”来了。

FDA取消了66家中国口罩商的FDA授权,使得获准出口美国的中国N95口罩制造商锐减至 14家。比亚迪“很幸运”留下来了。

但当初合同说了4月30日之前没拿到NIOSH认证,就要把一半定金退回。结果比亚迪4月 30日前没有拿到NIOSH认证。

现在情况是,比亚迪与加州政府还有新合同。5月31之前若没获得NIOSH认证,除了之前已 经退还的2.475亿美金,还得再退还2.475亿美金。

网友认为这就是美国的“仙人跳”,不过根据网络大V卢克文的求证,比亚迪说了,口罩没有发 货,这件事情对比亚迪本身没有损失,目前加州口罩订单情况是延期交付,而非取消。


网上也流传一份NIOSH的认证,比亚迪在口罩测试环节通过了,只是还没有拿到正式认证。


不过,加州一直喜欢“闹独立”,有人认为加州州长看来可能不会顾及政客们反对,力挺比亚迪。 而王传福接下来要怎样让这笔订单顺利进行,只能拭目以待。

无论今年口罩能给比亚迪怎样红利,口罩显然不会是比亚迪长期的利润增长点,随着疫情在明年或 者后年的基本褪去,比亚迪还将面临业务增长的“老问题”。

另外,电池业务是比亚迪的另一块“宝”,虽然目前占总营收比例不大,但是总能因科技含量高受 到瞩目。

最近,比亚迪的“刀片电池”成了焦点。“刀片电池”成分不同于传统磷酸铁锂或三元电池,在能 量密度上提高了50%,在热稳定性等方面都具有优势,有人认为,刀片电池对竞争对手宁德时代是一个挑战。

宁德时代要供货于特斯拉,产能也在扩大,随着特斯拉已经上海建厂投产,比亚迪无论在电池还是 汽车领域似乎都不占优势。

不过,在比亚迪的业绩预告中,预计今年上半年净利润为16-18亿,同比增长10%- 24%。预计的“底气”或许来自于2020年补贴及其他优惠政策的落地。

比亚迪的市值已经较曾经最高点跌去了1000多亿,这其中除了管理层近年策略问题,或许还有 整个汽车市场的萎靡。

随着今年国家一系列刺激消费政策出台,比亚迪能否借搭载刀片电池的比亚迪“汉”EV “扳回一局”?

只能靠时间给出答案。



最新地级市20强!三城GDP超万亿,苏州“无敌”  5-2020

中心城市对区域经济发展的作用日益凸显。除了直辖市、省会城市、计划单列市等,一些普通地级市 也可谓实力强劲。

记者梳理了2019年普通地级市GDP20强,其中排名前19位的城市均超过了5000亿元大 关,更有3个城市进入到GDP万亿俱乐部行列,分别是苏州、无锡和佛山。(来源:第一财经)


比 亚迪口罩出口受阻?官方回应:加州订单是延期并非取消

比亚迪N95口罩订单延迟交付,而非订单取消

5月11日,记者从知情人士处获悉,因比亚迪N95口罩的NIOSH认证时间延误, 导致产品5月的交付延迟,而非订单取消。

受影响的仅为N95口罩的交付,一次性医用口罩的交付未受影响,同时加州还追加了一次性医用口 罩的新订单。(来源:界面新闻)

@界面新闻:知情人士称,比亚迪还回去的是加州提前给的N95口罩部分订金,
    实际N95口罩还没有发货,此事对比亚迪没有造成损失。

@攀攀婆:和美国人做生意要小心翼翼。


新浪财经    发布时间:05-11 2020 新浪财经官方帐号  来源:新京报网     新京报记者 阎侠

原标题:比亚迪口罩出口受阻?官方回应:加州订单是延期并非取消

新京报讯(记者 阎侠)众所周知,新冠肺炎疫情之下,知名车企比亚迪也跨界做口罩了,并且自 称“目前全球最大量产口罩工厂”

根据比亚迪官网可知,1月底,在向湖北省捐赠1000万元现金、为抗疫前线人员捐赠价值 100万元防护物资的同时,
比亚迪决定援产口罩、消毒凝胶为抗疫助力,并迅速组建研发团队,成立了由王传福任责任人的专项小组

“比亚迪生产的口罩正在以每天30万到50万片的速度增加,每天5-10台左右的新口罩机器能 够实现量产,
     (100pc.min.,, 144,000pcs/day, 144Kx10=1.44M pcs) )

目前已达到每天500万只口罩的产能,这相当于之前全国产能的1/4  (??? Wrong!!!), 比亚迪成了目前全球最大量产口罩工厂。
 ”比亚迪官网3月13 日的消息显示。

近日,有媒体报道称“美国加州紧急事务办公室表示,由于未能在4月30日截止日期前拿到认 证,
比亚迪将退还该州为一单口罩购买合同所支付预 付款(4.95亿美元)的一半,即2.47亿美元。” 
 (Pay Advance directly from Calif State is Impossible. But, with guarantee from SoftBank that will be Possible. )

5月11日,比亚迪方面告诉新京报记者:“目前加州口罩订单的情况是延期交付而非取消,且对 订单中的一次性医用口罩交付没有影响。”

<>另外,比亚迪方面还表示:“除去国内口罩市场供应外,比亚迪和软银集团4月11日达成协议合作生产口 罩,
此外还拥有美国其他州及其他各个国家的订单,比亚迪正在加班加点生产口罩满足各方需求,因此加州口罩订单对公司经营影响不大。”

潇湘晨报    发布时间:05-11  2020  潇湘晨报官方百家号
此前,加州政府计划在2个月内向比亚迪采购3亿个N95口罩,每个口罩采 购价3.3 美元;  ( Qty too much, Price  too High, Time too short)
另外再采购 1亿个医用外科口罩,每 个采购价为0.55 美元
总的采购金额超过10亿美元。4月25日,300万个一次性医用 外科口罩已运到加州,这是比亚迪与加州政府签订合同后交付的第一批货。

比亚迪相关方面表示,比亚迪N95口罩的NIOSH认证时间延误,导致产品5月的交付延迟, 产品品质没有任何问题。此次受影响的仅为N95口罩的交付,一次性医用口罩的交付未受影响,同时加州还追加了一次性医用口罩的新订单。

比亚迪拿下美国加州近10亿美元口罩订 单

今年4月,据美国《洛杉矶时报》报道,比亚迪获得美国加利福尼亚州9.9亿美元的口罩订单。
加州州长加文纽瑟姆(Gavin Newsom)在也在电视节目中表示,
花费9.9亿美元从比亚迪一家美国 子公司采购口罩(1.5亿个N95,5000万个外科手术口罩),每月生产2亿个,合同有效期至6月底
其中大部分将是N95口罩,这是紧急救援人员和医护人员非常想要的。

近10亿美元的口罩大单,堪称是加州史上的最大口罩合同。在合同中,加州政府要求,在4月 30日前,比亚迪如果未获得国家职业安全与健康研究所(NIOSH)认证,要退还该合同定金的一半。不久前,就有媒体报道称,由于未能在4月30日截止日 期前拿到认证,比亚迪退还了口罩购买合同所支付的预付款(4.95亿美元)的一半,即2.47亿美元。

据了解,比亚迪如果未能在5月31日之前获得NIOSH认证, 加州将可以收回剩下的定金。
由于口罩的订单合同供应将持续到6月底,当前,比亚迪与加州的N95口罩订单仍处于延迟交付状态,
而最终订单能否顺利交付,NIOSH认证成为关键。

不过,值得注意的是,美国似乎正在收紧医疗物资相关许可。
5月7日, 美国食品药品管理局FDA撤回中国60多家制造商向美国出口N95口罩的许可,目前只剩下 14家,比亚迪还在里面。

比亚迪:N95口罩全球需求旺盛,此事 没有造成损失

新冠肺炎疫情发生以来,比亚迪积极投入防疫物资的生产大军,知名车企跨界转产口罩、洗手液 等,并且自称“目前全球最大量产口罩工厂”,
日产能达3000万片。4月28日,比亚迪在一季度财报中预测,由于“口罩生产预计将为集团的销售收入及盈利增长带来正面贡献”等因素,
2020年上半年公司净利润将在16亿元至18亿元之间,同比增长幅度在10%至23.8%之间。

对于此次加州N95口罩延迟交付,退还一半订金。比亚迪相关方面表示,没有造成损失,目前 N95口罩全球需求旺盛,
比亚迪还在不断增加产能,满足更多需求,帮助全球更多的人民一起抗疫。

据了解,比亚迪在美国加州之外还有其他州及世界其他国家的订单。今年4月11日,比亚迪和软 银集团与达成协议合作生产口罩,
5月开始出货,月产量3亿枚(其中医用N95口罩1亿枚,一般医疗用2亿枚)。

【来源:南方都市报】


目前,比亚迪300条口罩生产线日 产量达到了2000万只,并以每天100-200万只的速度增产,最大可以达到每天5000万只的产能。(300 ???)

据比亚迪官方介绍,截至4月17日,比亚迪口罩日产量已达2000万只,相当于每一秒钟有 231只口罩从比亚迪口罩产线下线。
目前,比亚迪集团已经建成了300条口罩产线,因国内外疫情防控需要,还在以每天生产100万到200万只口罩的速度 增产。

如此大的口罩产量除了供应国内,比亚迪也开始出口。最新的一个大单是美国加州与比亚迪签署价 值10亿美元的口罩订单。

比亚迪每月向加州供应大约2亿只口罩,其中大部分是防护级别更高的N95口罩。
10亿美元可 不是一个小数目,这个金额已占到去年比亚迪总营收的5%左右,这个“副业”着实令人艳羡。

自2月1日起,比亚迪就开设了两个生产线,从最初的日产500万只到4月中旬时日产2000万只, 并且还以每天增加300万个的速度扩大生产。
比亚迪拥有300条生产线,秒产231只口罩,怪不得成长这么快,这速度很多国家举全国之力都赶不上吧

向其他国家出售了数十亿只口罩,其中美国购买的约占比亚迪出售量的1/3,日本购入 的更是超过1半。

比亚迪与日本软银集团达成协议,自5月起,每月提供3亿个口罩。

4月9日,比亚迪获得美国食药局的授权,可向美国市场出口中国产标准的KN95口罩。
上月毕 业第接获了美国加州约10亿美元的大单口罩,谈妥后,比亚迪每月向其提供2亿只口罩,其中1.5亿只N95。

比亚迪与美国加州的一批口罩订单出了问题,而且还不是口罩问题。
已经有数千万只口罩抵达了美 国,但是有几百万只口罩在美国联邦认证出现了一些问题,导致4月30日前口罩没有得到美方的认证
,无法按时交付给加州当局。加州紧急事务办公室对外宣称, 根据与比亚迪签订的合同,比亚迪应该立即赔偿一半的预付款,约17亿元人民币。
之后加州又表示,在最新修订的合同里,如果比亚迪5月31日,还是被美国联 邦认证拒绝,那么另一半的预付款也必须全数退回。


4月30日,使出浑身解数的比 亚迪,依然没有拿到美国的NIOSH认证。这意味着比亚迪违约,必须退还2.47 亿美元给加州政府

加州共和党议员Kevin Kiley:“我州州长从中国比亚迪那里买口罩,3.3美元一个;洛杉矶市长从霍尼韦尔(美国本土厂商)买口罩,0.79美元一个。”

5月8日,据《华尔街日报》报道美国东部时间5月7日,美国食品和药物管理局(FDA)撤销 对中国大部分经过认证的N95口罩销售许可。

此前,中国已有约80家中国口罩制造公司拥有进入美国的进口许可范围。但现在,美国FDA撤 销中国82.5%口罩认证,仅留下14家。



全球新晋的第一口罩企业比亚迪目前日产量已超过2000万只以上,在股 神巴菲特的牵线下,获得了美国加州的一笔超过10亿美元的口罩大单,
其中以3.3美元/个的价格订购3亿个N95口罩,另以0.55美元/个的价格订购1 亿个医用口罩。

比亚迪正是在国人的忠告声中与美国加州签 下了口罩采购合约,不曾想还是中招了。

根据合约,美国加州政府预付比亚迪 4.95亿美元,但要求比亚迪必须在4月30日之前获得美国NIOSH(N95标准的制定者)认证,
否则将返还2.275亿美元的预付款;如果到5月31日比亚迪仍旧无法取得美国认证,将会退还所有的预付款。

近日,美国加州紧急事务办公室表示,由于 未能拿到认证,比亚迪将退还该州为一笔2.475亿美元的口罩购买合同预付款。

目前比亚迪通过美国认证的几率仍存在很大 不确定因素,5月7日,FDA以“达不到过滤95%”的标准为由,将出口美国的口罩企业批准名单由80家猛砍至14家。

比亚迪虽然还在名单中(有消息称,比亚迪 之所以还在名单中,是因为尚未得到FDA的检测),但形势并不乐观;现在比亚迪距离获得认证的最后期限已不足一个月,
而FDA二类申请周期一般在6~9个月,留给比亚迪的时间变 得越来越紧蹙;因此有媒体预判为“美国将白嫖中国口罩”。

对这次翻新版“石膏板”事件,中国的口罩 同行表现强烈,义乌市商务局率先于5月9日发出《关于暂停市场采购出口特定防疫物资的通告》,
要求从2020年5月10日零时起,暂停市场采购贸易方式出口新型冠状病毒检测试剂、医用口罩、医用防护服、呼吸机、红外体温计等医用物资和非医用口罩。

图片来源:义务商务局

比亚迪随后也于5月11日就加州追回预付 款一事进行回复,其主要表达了两个观点,
首先、“目前加州口罩订单的情况是延期交付而非取消,且对订单中的一次性医用口罩交付没有影响。”

该回应没有直接回复退回预付款事件前因后 果,而是将大众关注的重点转移到“延期而非取消”上,
且未说明为何延期交付还要退还定金,尤其是口罩一旦交付,美国加州是否还会支付货款避而不谈。


  口罩要进入美国,FDA认证及其重要。四月底,美国CDC下属机构国家职业安全卫生研究所,对中国不同厂家进口的67种口罩进行了检测,检测结果称,
约有60%的口罩在至少一个样本中的微小颗粒含量超过了美国标准通常允许的含量水平。通俗点讲,就是FDA对中国进口的67种口罩进行抽样检测,发现不符 合美国标准。



California to get $247M refund as masks face delivery delay

SACRAMENTO, Calif. (AP) — California will be refunded $247 million it paid to a Chinese company under a major deal for protective masks
after the company failed to meet a deadline for federal certification of the masks, Gov. Gavin Newsom’s administration said Wednesday.

Gov. Gavin Newsom announced the contract last month to fanfare, saying California had inked a nearly $1 billion deal for about 500 million protective masks
amid the coronavirus pandemic. Most were set to be tight-fitting N-95 respirator masks, while the rest would be surgical masks.
Millions of the surgical masks already arrived, but the company missed an April 30 deadline outlined in the contract for certification of the N95 masks
by the National Institute for Occupational Safety and Health.

The masks were set to start arriving this month, with tens of millions planned for shipment in May.
The governor’s office provided no details on what caused the certification delay.

The state paid about half the contract up front; the $247 million refund makes up roughly half of that initial payment.
Under an amendment to the contract Wednesday, the certification deadline has been pushed to May 31.
If that deadline isn’t met, the state will get back the rest of its money in June, according to the amendment.

The state paid $3.30 per N95 and 55 cents per surgical mask under the contract.
While the tighter-fitting masks are delayed, surgical masks have already started arriving in California under the deal,
Newsom said. The state made another $104.7 million payment it made last week for the delivery of the surgical masks,
and the amended contract makes no mention of returning that money.

Newsom said last month that the state and federal governments had “teams on the ground” in China auditing and visiting BYD’s factories.

“We are looking to make sure we do not procure what is not authorized and ultimately is not validated,” he said.

The masks must be certified through the National Institute for Occupational Safety and Health,
and they were to be be tested and validated in Utah, he said.
It wasn’t clear where the delay in the federal certification process occurred or whether the masks had yet arrived in the United States.

The release of the contract comes after Newsom’s administration declined for weeks to share it publicly, prompting criticism from lawmakers.
On Tuesday, the state’s Office of Emergency Services and Department of General Services denied the Associated Press’ request for the contract,
saying sharing it could jeopardize the delivery of the supplies.

But Newsom reversed course Wednesday, saying he wanted to share it with reporters and the public.

“We want to be as transparent as possible,” he said.

The surgical masks arrived earlier than planned, Newsom said.
The governor has become confident all the supplies would arrive and is more comfortable sharing the details of the contract.

Newsom said he wants to share the contract so people can see what a great price the state paid.
His administration said at the time the contract was made, other states were paying $6 to $7 per mask, with some paying more than $10 per mask.

The lack of information on the mask deal prompted criticism from state lawmakers,
who said they would have had more time to vet the deal under normal circumstances.
Documents from the treasurer’s office indicated Newsom’s administration hadn’t finished vetting BYD before Newsom publicly announced the contract or before
his administration asked the state treasurer’s office to prepare $495 million in an initial wire transfer.

When the treasurer’s office asked for confirmation the vendor had been vetted on April 8, the day after Newsom announced the deal on MSNBC,
Thomas Todd in the Department of Finance said “they’re vetting the vendor as we speak.”

The next day, an employee at the Office of Emergency Services told the treasury department that the state had worked with a “reliable NGO”
to source the contract and that the federal government and “large medical supply companies” also vetted the manufacturer, according to emails.

Republican Assemblyman Jay Obernolte, vice chairman of the Assembly Budget Committee, said he wished lawmakers had seen the contract sooner.
But he commended the governor’s office for its handling of the certification delay.

“I think that the administration is doing the best that they can to navigate a difficult situation with certification of those N95 masks,” he said.
___    Associated Press reporter Cuneyt Dil contributed.

 
作者:andyding
链接:https://xueqiu.com/9080548226/148741679
来源:雪球          著作权归作者所有。商业转载请联系作者获得授权,非商业转载请注明出处。

5-8-2020

美国食品与药物管理局(FDA)当地时间5月7日表示,撤销约60家中国制造商在美国销售N95口罩的许可,理由是这些制造商生产的口 罩无法针对新型冠状病毒提供足够的防护。

据彭博社的说法,FDA撤销了大约60家中国制造商向美国出口口罩的许可,留下14家公司获得授权。FDA表示,它还在加强对从中国进 口的口罩的检控,并将对这些口罩进行随机检测。

路透社称,FDA上月授权使用那些在中国制造的、经过认可的独立实验室测试的口罩,即使这些口罩没有经过美国有关部门的测试。

FDA撤回中国60多家制造商向美国出口N95口罩的许可!

5月7日,美国CDC国家职业安全与健康研究所(NIOSH)发布的最新检测发现,67 种不同类型的进口 N95 型口罩中,约有 60% 未达标。同一天,美国 FDA表示,撤回中国60多家制造商向美国出口N95口罩的许可,将中国获准为美国生产N95口罩的制造商数量从大约80家减少到14家。

据了解,这推翻了4月3日美国所做出的一项决定,即允许那些没有经过美国当局检测的制造商生产的口罩进口到美国,只要它们符合其他一些 国家设定的标准,或者经过一家独立实验室的审查。

不过,据消息人士表示,有国内企业的口罩并未出口美国,但仍发现 CDC 发布了其口罩的不合格报告 , 并且所附的检测样品照品也不是其公司的产品。CDC 也可能有失实报道,该企业正在要求 CDC 澄清。

与此同时,美国时间5月7日,FDA紧急发布了关于4月3号发布的口罩EUA的更新。主要的更新点如下:

1、修订资格标准,允许根据对独立实验室检测记录的标准的可接受的性能进行授权。

2、取消进口商作为EUA的申请人的资格,并指示制造商提供授权进口商的清单。

3、在可以被FDA验证的情况下,加了对中国国家医疗产品协会(NMPA)注册证书的认可。

附:FDA 授权进口的非 NIOSH 批准的中国口罩商名单(5月7日更新,获得FDA认证的只有14家)

编辑

美国CDC官网有一个NPPTL(The National Personal Protective Technology Laboratory)口罩检测结果的页面信息,部分企业也是美国EUA名单里的企业。网址:https: //www.cdc.gov/niosh/npptl/respirators/testing/NonNIOSHresults.html

简单比较后,下列EUA名单的企业有以下的检测结果:

事实上,中国口罩出口美国,遭遇的风波不止于此!

比亚迪卖口罩给美国,被迫退款2.47亿美元!

上个月,美国加州宣布与比亚迪达成一项价值约10亿美元的合同,并支付了近5亿美元预付款。根据合同,
比亚迪将在未来两个半月内向该州交付5亿个口罩,其中包括约3亿个N95口罩,每个价格为3.3美元。

然而,美国当地时间5月6日,美国加州紧急事务办公室表示,由于未能在4月30日截止日期前拿到认证,比亚迪将退还该州为一笔价值约 10亿美元的口罩合同支付的预付款的一半,即2.47亿美元。

据悉,这是新冠病毒疫情爆发以来,中国企业遭遇的最大“退款”事件。而退款原因,全部来自于“美国联邦认证的问题”。加州州长加文-纽 森称,该州向中国比亚迪公司订购的价值约10亿美元的口罩中,已有数千万个外科口罩运达,但数百万个原定本周运达的N95口罩因为联邦认证过程中的问题而 被延误了。他没有说明是什么造成了认证延误。

值得一提的是,在目前全球口罩紧缺的时刻,比亚迪卖给加州的这批口罩价格,甚至比美国其他州采购的价格便宜了整整一半。然而,本就是亏 本买卖的口罩生意,却还是遭遇了美国的“常规操作”。如果再次延误,最终比亚迪可能只能得到5.05亿美元货款。

中国驻美国大使崔天凯日前提到西方舆论中的一个奇怪现象。他说,当中方最初向美国和欧洲国家提供医疗物资时,有人说中方借此谋求地缘政 治利益。当中方在为确保出口医疗物资质量和符合国际标准出台了一些举措,有人又开始指称中方阻碍物资出口。

纵观美国FDA的“变脸”操作和比亚迪的此番惨痛教训,也给众多出口美国口罩等医疗物资的中国企业敲响一记警钟。

现在的口罩、防护服、呼吸机如果出口美国,相关企业一定要拿到美国的许可证,不要以为疫情蔓延期间急需防疫物资而可以突破许可证问题。

没证,即便现在人家拿走了,回头疫情过去了腾出手来一告一个准;即便拿到许可证了,还要看看清楚,自己产品够不够过硬,各种指标都符合 美国的要求,不然过了疫情还是一告一个准,出去卖了没多少钱,还不够律师费。

既然有了前车之鉴,我觉得我们现在最好的办法就是啥也别出口美国了,省的给自己惹官司赔钱。心中默念美国加油就好了。
Coronavirus  California to get $247M refund as masks face delivery delay

SACRAMENTO, Calif. (AP) — California will be refunded $247 million it paid to a Chinese company under a major deal
for protective masks after the company failed to meet a deadline for federal certification of the masks, Gov. Gavin Newsom’s administration said Wednesday.

Newsom announced the contract last month to fanfare, saying California had inked a nearly $1 billion deal for 200 million protective masks per month amid the coronavirus pandemic. Most were set to be tight-fitting N-95 respirator masks, while the rest would be looser-fitting surgical masks. Millions of the surgical masks already arrived,
but the company missed an April 30 deadline outlined in the contract for certification of the N95 masks by the National Institute for Occupational Safety and Health.

The respirator masks were set to start arriving this month, with tens of millions planned for shipment in May. The governor's office provided no details on what caused the certification delay.


The $247 million is half of an up-front payment the state made for the contract in April in an unusual move of making a payment before goods were delivered. The state could've clawed back all of its up-front payment under the original agreement, but an amendment signed Wednesday gives the company another month to meet the certification. If the masks aren't certified by May 31, California can get the rest of the payment back in early June.

The state paid $3.30 per N95 and 55 cents per surgical mask under the contract. The state made a seperate $104.7 million payment last week for the delivery of the surgical masks.

While the state initially sought 100 million surgical masks through the deal, it now plans to buy even more, according to the amendment, though it didn't include a specific number. The state and BYD must set an updated delivery schedule for the surgical masks by Friday.

A new payment and delivery schedule for the N95 masks must be set by May 22. Under the federal certification process, the final validation step would take place in Utah, Newsom said previously. It wasn't clear where the delay in the federal certification process occurred or whether the masks had yet arrived in the United States.


Newsom said last month that the state and federal governments had "teams on the ground" in China auditing and visiting BYD's factories.

Newsom's administration declined for weeks to share the contract publicly, prompting criticism from lawmakers. On Tuesday, the state's Office of Emergency Services and Department of General Services denied the Associated Press' request for the contract, saying sharing it could jeopardize the delivery of the supplies.

But Newsom reversed course, saying he wanted to release it to be "as transparent as possible." When the surgical masks began arriving, Newsom said he was confident the supplies would arrive and he became more comfortable sharing the details. He said the state's payment of $3.30 per mask was low compared to other states and federal buyers that had paid about $6 to $7 per mask.

The contract shows the agreement with BYD goes through June 2020, with an option for one-month extensions. It states everything made under the agreement must be "newly manufactured" and that the company cannot use sweatshop, forced, child or other controversial labor practices. The company has in the past faced accusations of unfair labor practices.

While the masks will be made in China, the contract requires the company to comply with various U.S. and California environmental and labor laws.

Republican Assemblyman Jay Obernolte, vice chairman of the Assembly Budget Committee, commended Newsom's administration for "doing the best that they can to navigate a difficult situation" with certification of the masks. But he was frustrated they waited so long to release the contract.

"Our frustration is the Legislature has a constitutional duty to provide spending oversight over these taxpayer resources, and we feel like we have not been able to exercise that duty in the last six weeks," he said.

Documents from the treasurer's office indicated Newsom's administration hadn't finished vetting BYD before Newsom publicly announced the contract or before his administration asked the state treasurer's office to prepare the initial wire transfer.

When the treasurer's office asked for confirmation the vendor had been vetted on April 8, the day after Newsom announced the deal on MSNBC, Thomas Todd in the Department of Finance said "they're vetting the vendor as we speak."

This isn't the first time California wired money that was then returned for masks. In March, California wired nearly half a billion dollars to Blue Flame Medical LLC for 100 million masks, but canceled the deal and got its money back later that day, CalMatters reported on Wednesday.

Separately, the state was refunded $8.7 million less than two weeks after wiring the amount to a company with a Florida address, Hichens Harrison Capital Partners, according to documents from the treasurer's office. The company, which has a subsidiary in Brazil and business with China, currently advertises an "exclusive line of ventilators" on its website.

In an April 13 email to California officials, Peter Leite, the president of Hichens Harrison Capital Partners, wrote the order was canceled and the money would be returned. Leite referred questions about the canceled transaction to the state on Wednesday. Spokesman for the governor's office and the Office of Emergency Services didn't immediately answer questions about the transaction.


Newsom's Mask Deal Shows Tendency for Big Plans, Few Details
Gov. Gavin Newsom's recent announcement that California signed contracts to buy 200 million masks per month in the first against coronavirus was bold.
By Associated Press, Wire Service Content April 15, 2020, at 2:28 p.m.In this photo taken Tuesday April 14, 2020, Gov. Gavin Newsom discusses an outline for what it will take to lift coronavirus restrictions during a news conference at the Governor's Office of Emergency Services in Rancho Cordova, Calif. California lawmakers are launching hearings Thursday to gather more details on Newsom's spending during the pandemic and the $1 billion contract he entered for protective masks. AP Photo/Rich Pedroncelli) The Associated Press

By KATHLEEN RONAYNE, Associated Press

SACRAMENTO, Calif. (AP) — California Gov. Gavin Newsom's announcement was audacious:
On a national news show, he said the state had just inked a deal to buy 200 million masks monthly,
a massive haul amid the international scramble for protective gear needed in the fight against the coronavirus.

By KATHLEEN RONAYNE, Associated Press

SACRAMENTO, Calif. (AP) — California Gov. Gavin Newsom's announcement was audacious: On a national news show, he said the state had just inked a deal to buy 200 million masks monthly,
a massive haul amid the international scramble for protective gear needed in the fight against the coronavirus.

“As a nation-state, with the capacity to write a check for hundreds of millions, no billions, of dollars,
we’re in a position to do something bold and big,” Newsom told reporters the next day.

The announcement surprised many state lawmakers, and California took the unusual step of paying half the cost up front.
One week later, details of the $1 billion deal with Chinese company BYD are limited —
the contract has not been made public, though Newsom's emergency services director said it would be soon.

The mask deal, and how Newsom announced it, illustrates the first-term governor’s tendency to make big pronouncements without all details in place, or before his administration is ready to share them.

Lawmakers will begin oversight hearings Thursday to learn more about the deal and Newsom's spending during the pandemic after they halted their session last month and gave him broad authority to spend. He's spent nearly $2 billion.

Democratic state Assemblyman Richard Bloom, a budget committee member, said details of the BYD deal “are very murky."

“One thing that I am concerned about is the lack of dialogue between the administrative and legislative branches of government about emergency expenditures,” Bloom said in a statement.

Newsom “has moved swiftly and aggressively to protect human life and help Californians meet unprecedented challenges," his spokesman Nathan Click said in a statement. He added, "because of those efforts and the actions of millions of Californians who are staying home, California has begun to flatten the curve and has even been able to assist other states that are in much worse shape.”

In another big claim, Newsom last month praised a “heroic effort” by Tesla founder Elon Musk to donate at least 1,000 ventilators to California hospitals and said Musk would work with the state's hospital association and other groups to deliver them.

But on Wednesday, state spokesman Brian Ferguson said the state had not heard of any hospital systems receiving ventilators
from Musk or Tesla. California Hospital Association spokeswoman Jan Emerson-Shea said the organization played no role in distributing ventilators. Tesla spokesman Kamran Mumtaz did not immediately respond to an email seeking comment.  

Newsom has also offered conflicting information on plans to house homeless Californians vulnerable to the virus. When he issued an executive order last month that he promoted as a 60-day eviction moratorium, advocacy groups said it didn’t adequately protect tenants. They won approval of a more iron-clad moratorium from the state’s Judicial Council

Newsom speaks daily about the state's response to the outbreak, giving hour-long presentations replete with numbers he recites with precision. He is dyslexic and memorizes most of his presentations.

“One of the downsides of speaking extemporaneously is you may get some of the details wrong, especially when you are speaking for an hour straight,” said Kim Nalder, a professor of political science at the California State University, Sacramento. But, she said, “he’s definitely projecting a sense of comprehending the situation and aggressively addressing the issues.”

California, the most populous U.S. state, has fewer infections and deaths than New York and several other states. More than 25,000 Californians have tested positive for the virus and nearly 800 have died. For most people, the virus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause life-threatening illness and death.

Six counties in the San Francisco Bay Area were the first in the country to impose stay-at-home orders, and Newsom followed with a statewide directive.

Karin Michels, chair of the epidemiology department at the University of California, Los Angeles’ Fielding School of Public Health, said California has been aided in its virus fight by cultural factors like its low-density housing, younger population and residents' overall health. But she said the governor deserves “a lot of credit for being quick.”

Still, state lawmakers and advocacy groups are agitated by aspects of Newsom's approach.

Lawmakers want to know how the state is ensuring the quality of the masks Newsom ordered and how they'll be distributed.

BYD is an electric vehicle manufacturer that recently started making masks at its facilities in China and its North American headquarters is in Los Angeles. A 2018 Los Angeles Times investigation found BYD buses purchased by the county transit agency had mechanical and performance issues, though the county and other agencies continued contracting with the company. Congress, meanwhile, recently banned BYD and another Chinese company from winning federal transit contracts over national security concerns.

Newsom and Mark Ghilarducci, head of California’s Office of Emergency Services, said BYD was thoroughly vetted and that its bus business is separate from the mask deal.

Company spokesman Frank Girardot said BYD will “absolutely, 100%” comply with U.S. rules and certifications.
The first masks are expected to arrive in late April or early May.  

Newsom's mask deal shows tendency for big plans, few details
[Associated Press]     KATHLEEN RONAYNE       ,Associated Press•April 16, 2020
    SACRAMENTO, Calif. (AP) — California Gov. Gavin Newsom's announcement was audacious: On a national news show, he said the state had just inked a deal to buy 200 million masks monthly, a massive haul amid the international scramble for protective gear needed in the fight against the coronavirus.

“As a nation-state, with the capacity to write a check for hundreds of millions, no billions, of dollars, we’re in a position to do something bold and big,” Newsom told reporters the next day.

The announcement surprised many state lawmakers, and California took the unusual step of paying half the cost up front. One week later, details of the $1 billion deal with Chinese company BYD are limited — the contract has not been made public, though Newsom's emergency services director said it would be soon.

The mask deal, and how Newsom announced it, illustrates the first-term governor’s tendency to make big pronouncements without all details in place, or before his administration is ready to share them.

Lawmakers will begin oversight hearings Thursday to learn more about the deal and Newsom's spending during the pandemic after they halted their session last month and gave him broad authority to spend. He's spent nearly $2 billion.

Democratic state Assemblyman Richard Bloom, a budget committee member, said details of the BYD deal “are very murky."

“One thing that I am concerned about is the lack of dialogue between the administrative and legislative branches of government about emergency expenditures,” Bloom said in a statement.

Newsom “has moved swiftly and aggressively to protect human life and help Californians meet unprecedented challenges," his spokesman Nathan Click said in a statement. He added, "because of those efforts and the actions of millions of Californians who are staying home, California has begun to flatten the curve and has even been able to assist other states that are in much worse shape.”

In another big claim, Newsom last month praised a “heroic effort” by Tesla founder Elon Musk to donate at least 1,000 ventilators to California hospitals and said Musk would work with the state's hospital association and other groups to deliver them.

But on Wednesday, state spokesman Brian Ferguson said the state had not heard of any hospital systems receiving ventilators from Musk or Tesla. California Hospital Association spokeswoman Jan Emerson-Shea said the organization played no role in distributing ventilators. Tesla spokesman Kamran Mumtaz did not immediately respond to an email seeking comment.

Newsom has also offered conflicting information on plans to house homeless Californians vulnerable to the virus. When he issued an executive order last month that he promoted as a 60-day eviction moratorium, advocacy groups said it didn’t adequately protect tenants. They won approval of a more iron-clad moratorium from the state’s Judicial Council

Newsom speaks daily about the state's response to the outbreak, giving hour-long presentations replete with numbers he recites with precision. He is dyslexic and memorizes most of his presentations.

“One of the downsides of speaking extemporaneously is you may get some of the details wrong, especially when you are speaking for an hour straight,” said Kim Nalder, a professor of political science at the California State University, Sacramento. But, she said, “he’s definitely projecting a sense of comprehending the situation and aggressively addressing the issues.”

California, the most populous U.S. state, has fewer infections and deaths than New York and several other states. More than 25,000 Californians have tested positive for the virus and nearly 800 have died. For most people, the virus causes mild or moderate symptoms, such as fever and cough that clear up in two to three weeks. For some, especially older adults and people with existing health problems, it can cause life-threatening illness and death.

Six counties in the San Francisco Bay Area were the first in the country to impose stay-at-home orders, and Newsom followed with a statewide directive.

Karin Michels, chair of the epidemiology department at the University of California, Los Angeles’ Fielding School of Public Health, said California has been aided in its virus fight by cultural factors like its low-density housing, younger population and residents' overall health. But she said the governor deserves “a lot of credit for being quick.”

Still, state lawmakers and advocacy groups are agitated by aspects of Newsom's approach.

Lawmakers want to know how the state is ensuring the quality of the masks Newsom ordered and how they'll be distributed.

BYD is an electric vehicle manufacturer that recently started making masks at its facilities in China and its North American headquarters is in Los Angeles. A 2018 Los Angeles Times investigation found BYD buses purchased by the county transit agency had mechanical and performance issues, though the county and other agencies continued contracting with the company. Congress, meanwhile, recently banned BYD and another Chinese company from winning federal transit contracts over national security concerns.

Newsom and Mark Ghilarducci, head of California’s Office of Emergency Services, said BYD was thoroughly vetted and that its bus business is separate from the mask deal.

Company spokesman Frank Girardot said BYD will “absolutely, 100%” comply with U.S. rules and certifications. The first masks are expected to arrive in late April or early May.