前言 2024年9月24日,FDA发布了一篇在2019年11月24日给Takeda Pharmaceutical Company Limited的483,一共出了7个发现项,涉及质量体系、生产系统、实验室控制系统以及设施和设备系统的问题。 以下是课代表对报告中观察项的总结: 质量体系: 质量控...
开了483，一般都是发现了很严重的不合格项。483不是warning letter. 483是FDA的那个写inspection observa...
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 ...
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. 1. Your firm’s quality control unit failed to exerci...
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, Investigator Thom...
我们仔细审查了您于 2024 年 4 月 18 日对我们提交的 FDA 483 表格的回复。 在检查过程中,我们的调查员观察到以下具体违规行为,包括但不限于: 1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product con...
Specifically, your company has received several complaints from customers regarding out-of-specification (OOS) results, observed when the customer performs API acceptance tests, after an API is shipped by and received from your company....
FDA 483 表:Hospira Inc. A Pfizer Company Date Posted/发布日期:12/06/2018 A. 留样检查员/操作员通过 XX 目视检查培训计划进行培训,该计划要求使用 XX 进行资 格确认。你没有文件化的科学证据证明为什么 XX 是所有主要容器封闭系统(如安瓿(约 1mL-5mL)、琥珀色小瓶、100mL 瓶等)的代表或最差情况。 B...
9、dence or documentation collected on-site, and any responses made by the company.The Agencyconsiders all of this information and then determines what further action, if any, is appropriate to protect public health.美国FDA483回复的10条技巧每次FDA检查官完成现场检查时,都会给药业负责人发一份 CGMP...
FDA also faulted the company for trending only for a limited number of time points, the team noted in the 483. Again, Cambridge referenced the stability protocol that required a study only for long-term conditions for midodrine HCI. The corrective and preventive actions noted for the previous ...