一、FDA - Form 483美国食品药品管理局（FDA）履行其监督的职责，有数千种不同的表格，每一种表格所管理的事项不同，为了区分不同的表格，FDA对不同的表格分配了不同的编码。1️⃣ FDA 483 是指美国食品药品监督管理局（Food and Drug Administration）在进行现场检查时，如果发现有违反...
We reviewed your March 7, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. 我们详细审查了您2024 年 3 月 7 日对 FDA 483 表格的回复,并确认收到您随后的信件。 During our inspection, our investiga...
大连辉瑞违反GMP操作 FDA483表中英对照版 这是最近网上流传的大连辉瑞FDA检查的483表。从扫描件来看，并没有全，甚至一些发现的缺陷也没有扫描全，所以各位在阅读时，请注意。在最后附上了网上流出的扫描原件。翻译内容仅供参考，并且没有经过复核，如有分歧，请以原件为准。欢迎发送邮件至myuiconfig@126.com交流，...
The firm also explained that although the cleaning procedure had been revised, the form was unchanged, but the blank pages in the logbook had not been updated with the correct version number. To address these issues, the company revised its cleaning procedure to establish requirements regarding th...
FDA在2023年06月26至07月04日,对位于瑞士的UCB Farchim SA工厂进行了检查, 并于10月24日在其网站上披露了这份483。共计4条发现项,其中前2条与数据可靠性相关。 OBSERVATION1 发现项1 Quality unit oversight over qualitycontrol operations is deficient, including laboratory and productionselectronic systems ...
We reviewed your March 7, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. During our inspection, our investigators observed specific violations including, but not limited to, the following. ...
We reviewed your March 17, 2020, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. 我们已详细审核了你公司XXXX年XX月XX日的回复,并此告知已收到后续通信。 During our inspection, our investigators o...
13、cturing, testing facility/ies (to facilitate pre-approval inspections)Detailed description of manufacturing process.Flow diagram (from weighting to FP release; identify critical steps) .Blank batch and packaging record for production batch.Manufacturing and controls (cont.)Executed batch recordsProc ...
However, the investigation section of the complaint form is blank. d.贵公司收到了2020年1月3日的投诉20-003-01,该投诉称臀部植入物因肿胀而被移除。然而,投诉表格的调查部分是空白的。 e. Your firm received complaint 20-008-01 dated January 8, 2020 which reported a pectoral implant was removed ...
f. The presence of numerous blank documents that had been printed from the Doc Control system including, but not limited to: Form QA2529 “Raw Material Checklist”, Form QA7 “Regeneron General Training Documentation Form', Form V11798 “QC Virology Sample Transmittal and Test Analysis Request ...