Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI (Official Action Indicated). Biocon Malaysia was inspected by USFDA in July 2023 resulting in USFDA 483 with eight observations on GMP violations. The observations included poor aseptic practices by Operators in sterile operations, inadequate failure investigations (see Qvents post). The statement said Biocon has submitted comprehensive CAPA plan to USFDA and is on track to close actions expeditiously.
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