The FDA last week sent a warning letter to China-based Sichuan Deebio Pharmaceutical after a September inspection led to data integrity and other quality control questions.
Sichuan Deebio Pharmaceutical Co. Ltd. Received FDA Warning Letter
When it comes to what not to do during an FDA inspection of your drug ingredient manufacturing facility, having the plant’s quality control chief intentionally give investigators the runaround by fibbing about the existence of testing logs ranks high on the list.
Chinese API manufacturer Sichuan Deebio Pharmaceutical received an “official action indicated” classification following a September Form 483 detailing quality control and batch discrepancy issues.
FDA Issues Form 483 to Sichuan Deebio Pharmaceutical Co. Ltd.