Typically, the most effective way to write your response is in narrative form. State the observation and address it in a clear, chronological format allowing you to put your company in the best light possible. 通常,最有效的回复方式是以叙述的形式。陈...
根据程序001-001698《注射用产品操作的无菌人员监控》,所有进入无菌生长室的人员都必须在1698-FORM-01《无菌区进入日志》中签名并记录进入的日期和时间。 西门:这个回复,其实也就是说,人流控制所产生记录以纸质记录为主,纸质记录控人流,这里其实还是建议,用纸质最放心。 Deviation 40224147 was initiated to investigate...
483不是warning letter. 483是FDA的那个写inspection observations的表格是form 483.
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...
| 483表格 | This form with the eponymous number 483 is used by the executing Inspector (FDA Investigator) to document the deficiencies he found. It is issued at the end of the inspection and should be answered officially. Th...
1.没有听说过“缺陷信”这种说法,当然我想你指的就是483了。一般我就管他叫483,中文大概叫“现场观察报告”?; 2.483和警告信(warningletter)不是一个东西。483是“InspectionalObservations”,这份表格编号是“FormFDA483”.这一点,SunnyGao已经解释过啦~所以,针对题主的问题,为什么叫483?就因为这个表格编号是form...
records in an aseptic processing area of a drug manufacturing facility. None of the deviations excerpted here are unique, but all are avoidable.After the excerpts, we outline some best practices of a 483 response,providing a 10-point checklist (to make that 15-day time limit more manageable) ...
in the mail, without prior notification from FDA. Before a Warning Letter is issued, the FDA requests the company to comment on the deficiencies listed in the Form 483 Observations found during the inspection. If the FDA judges this response to be unacceptable, a Warning Letter will be issued...
the FDA issues warning letters .If the response is unsatisfactory to the warning letters it may lead to further actions like suspension/cancellation of the manufacturing license, refuse to give product approval, import refusal of the products .The companies may avoid getting form 483 if they have...
对于 2024 财年，FDA 承诺在收到会议请求后 30 天内对 50% 符合资格的会议请求作出批准、拒绝或推迟...