FDA Form 483 due to Particle Findings in a ProductFDA由于在产品中发现颗粒物签发的483表
The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of their facility in May and June 2017. Form 483 is used by FDA inspectors to document deficiencies found during an inspection. After the inspection, this document is sent to the inspected company in order for them to comment on the deficiencies described. If the deficiencies aren't eliminated or the statement by the company is insufficient in the eyes of the FDA, a Warning Letter by the agency follows. Contrary to FDA Warning Letters, Form 483 reports are not all freely available. The FDA only publishes some selected documents on their website "Frequently requested or proactively posted compliance records". During the inspection mentioned above, several GMP violations were recorded:
韩国CELLTRION公司于2017年5月和6月一次检查中收到FDA签发的所谓483表。483表是FDA检查人员用于记录检查期间发现的缺陷的。在检查完成后，该文件会被发送给受检公司，让他们对所述缺陷给出意见。如果缺陷未被消除，或者是公司所作的声明在FDA看来不够充分，则紧跟着会签发一封警告信。与FDA警告信相反，483表格并不是可以自由获取的。FDA只发布一些经过选择的文件放在其官网上。在上述检查期间，记录了几个GMP违规情况如下：
There was no timely investigation of particles found in a product: a contract laboratory reported an OOS concerning particle findings on 3 February 2017. The corresponding investigation hadn't been performed until 28 February. The company received further samples on 13 April, which hadn't been investigated by 31 May, though. Furthermore, a stability study performed on 16 March found numerous particles ("too numerous to count") regarded as intrinsic protein agglomerates. It turned out however, that there were foreign particles, as well. Until 31 May, no root investigation was conducted. Further particles found during visual control hadn't been investigated, either, e.g. to determine their source. Vials which had been rejected because of particles hadn't been considered in the test kits for training or qualification.
公司未对产品中发现的颗粒物进行及时调查：公司的一个外包化验室于2017年2月3日报告了一个发现颗粒物的OOS，直到2月28日仍未进行相应的调查。公司在4月13日是收到了更多样品，直到5月31日仍未开始调查。还有，3月16日是实施的稳定性试验发现了大量颗粒物（太多无法计数），被认为是固有的蛋白质聚集体。最后显示这些其实也是外来颗粒物。直到5月31日，仍未进行根本原因市井。在目视控制中发现了更多的颗粒物也没有进行调查，例如，以确定其来源。安瓿瓶由于在检测培训或资格确认包中没有考虑颗粒物，因此安瓿瓶被拒收了。
Further deficiencies can be found in the FDA inspection review, as well: reviews about environmental monitoring hadn't been completed in a timely manner, and occurring trends hadn't been investigated. During the aseptic work, employees were observed leaning over sterile surfaces and plugs in the RABS with their arms; in another instance, the RABS had been left open unnecessarily. Deficiencies have been observed during Media Fill, also. For example, 19 vials had been rejected as "fallen from the conveyor" and not microbiologically investigated, even though they had been integral and stoppered. In routine operations and according to procedures, these vials wouldn't have had to be rejected. The FDA found further deficiencies in process validation, lab data (which didn't contain all the results of the tests performed) and equipment design. For example, identification numbers were taped to format parts inside of the RABS.
在FDA的检查审核中可以发现更多缺陷，如：对环境监测的审核未及时完成，发生的趋势未进行调查。在无菌工作中，发现雇员俯身向无菌表面，将其手臂插入RABS中；在另一个例子中，RABS没有原因就那么打开着。在培养其灌装中也发现了缺陷。如，有19瓶曾被拒，原因是“从传送带上跌落”，虽然这些瓶子都没有封装完整也没有加塞，但并没有进行微生物调查。FDA在工艺验证、化验室数据（其中未包括所实施的检测的所有结果）和设备设计中发现了更多的缺陷。例如，格式化零件是在RABS内录上识别号的。
On the FDA website you can find the complete Form 483 report.
完整483表可以在FDA官网上找到。
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推荐转载 20171030 ECA新闻：FDA批评工艺验证缺陷 FDA警告信：加拿大Aztex Enterprises Ltd. 20171020历史上的今天
201409:FDA行业指南：ANDA申报---拒绝受理杂质限度缺乏适当论述2014-10-31 15:33:14
那一天，我闭目在经殿2010-10-31 20:43:17
恐龙化石2010-10-31 19:37:07
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The company Celltrion in South Korea received a so-called Form 483 report as a result of an inspection of their facility in May and June 2017. Form 483 is used by FDA inspectors to document deficiencies found during an inspection. After the inspection, this document is sent to the inspected company in order for them to comment on the deficiencies described. If the deficiencies aren't eliminated or the statement by the company is insufficient in the eyes of the FDA, a Warning Letter by the agency follows. Contrary to FDA Warning Letters, Form 483 reports are not all freely available. The FDA only publishes some selected documents on their website "Frequently requested or proactively posted compliance records". During the inspection mentioned above, several GMP violations were recorded:
韩国CELLTRION公司于2017年5月和6月一次检查中收到FDA签发的所谓483表。483表是FDA检查人员用于记录检查期间发现的缺陷的。在检查完成后，该文件会被发送给受检公司，让他们对所述缺陷给出意见。如果缺陷未被消除，或者是公司所作的声明在FDA看来不够充分，则紧跟着会签发一封警告信。与FDA警告信相反，483表格并不是可以自由获取的。FDA只发布一些经过选择的文件放在其官网上。在上述检查期间，记录了几个GMP违规情况如下：
There was no timely investigation of particles found in a product: a contract laboratory reported an OOS concerning particle findings on 3 February 2017. The corresponding investigation hadn't been performed until 28 February. The company received further samples on 13 April, which hadn't been investigated by 31 May, though. Furthermore, a stability study performed on 16 March found numerous particles ("too numerous to count") regarded as intrinsic protein agglomerates. It turned out however, that there were foreign particles, as well. Until 31 May, no root investigation was conducted. Further particles found during visual control hadn't been investigated, either, e.g. to determine their source. Vials which had been rejected because of particles hadn't been considered in the test kits for training or qualification.
公司未对产品中发现的颗粒物进行及时调查：公司的一个外包化验室于2017年2月3日报告了一个发现颗粒物的OOS，直到2月28日仍未进行相应的调查。公司在4月13日是收到了更多样品，直到5月31日仍未开始调查。还有，3月16日是实施的稳定性试验发现了大量颗粒物（太多无法计数），被认为是固有的蛋白质聚集体。最后显示这些其实也是外来颗粒物。直到5月31日，仍未进行根本原因市井。在目视控制中发现了更多的颗粒物也没有进行调查，例如，以确定其来源。安瓿瓶由于在检测培训或资格确认包中没有考虑颗粒物，因此安瓿瓶被拒收了。
Further deficiencies can be found in the FDA inspection review, as well: reviews about environmental monitoring hadn't been completed in a timely manner, and occurring trends hadn't been investigated. During the aseptic work, employees were observed leaning over sterile surfaces and plugs in the RABS with their arms; in another instance, the RABS had been left open unnecessarily. Deficiencies have been observed during Media Fill, also. For example, 19 vials had been rejected as "fallen from the conveyor" and not microbiologically investigated, even though they had been integral and stoppered. In routine operations and according to procedures, these vials wouldn't have had to be rejected. The FDA found further deficiencies in process validation, lab data (which didn't contain all the results of the tests performed) and equipment design. For example, identification numbers were taped to format parts inside of the RABS.
在FDA的检查审核中可以发现更多缺陷，如：对环境监测的审核未及时完成，发生的趋势未进行调查。在无菌工作中，发现雇员俯身向无菌表面，将其手臂插入RABS中；在另一个例子中，RABS没有原因就那么打开着。在培养其灌装中也发现了缺陷。如，有19瓶曾被拒，原因是“从传送带上跌落”，虽然这些瓶子都没有封装完整也没有加塞，但并没有进行微生物调查。FDA在工艺验证、化验室数据（其中未包括所实施的检测的所有结果）和设备设计中发现了更多的缺陷。例如，格式化零件是在RABS内录上识别号的。
On the FDA website you can find the complete Form 483 report.
完整483表可以在FDA官网上找到。
阅读(24)| 评论(0)
推荐转载 20171030 ECA新闻：FDA批评工艺验证缺陷 FDA警告信：加拿大Aztex Enterprises Ltd. 20171020历史上的今天
201409:FDA行业指南：ANDA申报---拒绝受理杂质限度缺乏适当论述2014-10-31 15:33:14
那一天，我闭目在经殿2010-10-31 20:43:17
恐龙化石2010-10-31 19:37:07
在LOFTER的更多文章评论 登录后你可以发表评论，请先登录。登录>> 我的照片书 - 博客风格 - 手机博客 - 下载LOFTER APP - 订阅此博客网易公司版权所有 ©1997-2017
