[9] FDA. Drug recalls[EB/ OL]. [2022 - 10 - 18]. https:/ / www.fda. gov/ drugs/ drug⁃safety⁃ and⁃availability/ drug⁃recalls. [10] 国家药典委员会. 中华人民共和国药典[S]. 2020 年版. 四部. 北京:中国医药科技出版社, 2020:2 -5. [11] USP. Injections and Implanted Dru...
[8] 郭艳争. 小容量注射剂可见异物影响因素分析和处理措施[J]. 当代化工研究, 2016(3):7 -8. [9] FDA. Drug recalls[EB/ OL]. [2022 - 10 - 18]. https:/ / www.fda. gov/ drugs/ drug⁃safety⁃ and⁃availability/ drug⁃recalls. [10] 国家药典委员会. 中华人民共和国药典[S]. 20...
the agencyannounced Monday.The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Thoratec Corp., a subsidiary of Abbott Laboratories. The devices are not currently being removed from the ...
[9]FDA.Drugrecalls[EB/OL].[2022-10-18].https://www.fda.gov/drugs/drug⁃safety⁃ and⁃availability/drug⁃recalls.[10] 国家药典委员会. 中华人民共和国药典[S].2020 年版. 四部. 北京:中国医药科技出版社, 2020:2-5.[11]USP.InjectionsandImplantedDrugProducts(Parenterals)⁃ProductQuality...
include FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EUreports of GMDP noncompliance. This article presents themost recent publication of GMP drug inspection data,which address dr...
Drug Recalls Put FDA on the Hot Seat.(Knight Ridder/Tribune Business News)Silverman, Edward R
include FDA Form 483s, Establishment Inspection Reports, warning letters, recalls, import alerts, consent decree agreements, MHRA annual summaries of inspection deficiencies, and EUreports of GMDP noncompliance. This article presents themost recent publication of GMP drug inspection data,which address dr...
我们确认收到你们2020年7月2日的信件。但是,对于我们在FDA 483表中检查期间发现的观察项,你们没有提供具体信息或纠正措施的证据。 During the inspection, you told the FDA investigator that you would stop making drug products and plan to outsource the manufa...
We further acknowledge your decision to recall all drug products that you repackaged into heat-sealed pouches with one transparent side instead of a light-resistant container closure system. 我们进一步确认,知晓您决定召回所有含透明面包装的热封袋药品(非耐光容器封闭系统)。
o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls. O行动计划和时间表:对留样进行全面的化学和微生物检验,以确定分发给美国的药品批次(...