Wednesday, July 11, 2018

Warning Letter of the Week: throw it all in there edition

A note from the Center for Drug Evaluation and Research to the General Manager of Foshan Jinxiong Technology Co., Ltd.: 
4.    Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
You lacked complete information related to the production and control of each lot. For example, you failed to have specific identification for each  lot of component, and production equipment, used in manufacturing. You also failed to have unique lot or control numbers for the distributed drug product. You provided our investigator with a list of more than [redacted] batches manufactured in 2017 that lacked this basic information.

In your response, you described your new lot numbering system and how you revised your production records. You also provided a copy of the revised production record.
Figuring out a way to accurately and robustly number manufacturing batches is a non-trivial task. Not numbering them at all is a pretty bold and simple solution! 

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