Specifically,具体来说 (A)We observed the presence and use of executed batch manufacturing records that were not identified in the records presented during the inspection. When requested for the complete list of executed batches for (b)(4) Capsu...
本文从FDA官网的首页开始,简单介绍了FDA官网各模块的内容,又详细介绍了从事药品研发、注册、生产及质量研究人员重点关注的模块“Drugs”和“Vaccines, Blood, and Biologics”内容,明确了药品行业法规、指南、警告信、483缺陷以及FDA会议、培训的入口路径,为广大医药工作人员提供快速了解FDA动...
FDA-483报告解读 1 FDA 483 for Hospira Rocky Mount 2013 检查 期: 02/12/2013-03/01/2013 To: Zena G. Kaufman, Senior Vice President, Global Quality Hospira, Inc.Hwy. 301N. +4285 North Wesleyan Blvd.Rocky Mount, NC 27804 Sterile Pharmaceutical Manufacturer FDA 检察官:Penny H. McCarver...
to receive a Form 483 (“Notice of Inspectional Observations”). In such stringently controlled industries as pharmaceutical/ biotechnical development, manufacturing and warehousing, receiving a list of deficiencies can feel like a heavy blow to your quality system. Worse, with the 2009 increase in ...
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. ...
免费在线预览全文 GMP 最前沿第期最前沿第期 最前沿最前沿第期第期 增刊增刊 增刊增刊 2013 FDA 483 解读里里解读里里Hospira 解读解读里里里里 翻译余曦赵谦张放周文 校对和解读赵谦 药注GMP 俱部 俱部QQ 群292669664 GMP 最前沿 1 FDA 483 for Hospira Rocky Mount 2013 检查期检查期: 02/12/2013-03/01...
我们已详细审核了你公司于2019年11月7日对FDA 483表格的回复,并此告知已收到后续通信。 During our inspection, our investigators observed specific violations and deviations including, but not limited to, the following. 检查期间,我们的调查人员发现的具体问题包括但不仅限于以下: ...
FDA 483 指导手册说明书 Guide for US FDA-Regulated Organizations “How to Respond to (and Avoid) FDA Form 483s for Temperature, Humidity and other Controlled Environments”By Ken Appel, VP of Regulated Markets Veriteq, a Vaisala company ...
除了483表以外,检查员还要制作EIR。EIR要在30个工作日内完成,然后交由FDA地区办公室或中央办公室负责人检查,检查后会被识别为以下几种状态: NAI: No Action Indicated - there were no objectionable items found during the inspection NAI:不需要采取措施---在检查期间没有发现违规项目(“零缺陷”) VAI: Volunt...
公司的产品不能再出口至美国。产品将被美国海关执行DWPE(不经检查即扣留)。亦有483后不开警告信直接导致禁令的情况。 Debarment List 排除清单 该清单包括了所有不允许生产销往美国的药品的公司。排除清单是公开的。 Court - Consent Decree 法院---法令。