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Warning letters, 483s, Recalls, Import Alerts, Audit observations

USFDA 483 / IPCA / June 2023 /Inadequate

IPCA unit at Dhar, Madhya Pradesh, India USFDA 483 cites Invalidation of OOS with inconclusive

Qvents
August 2, 2023

IPCA unit at Dhar, Madhya Pradesh, India

Failure to thoroughly review unexplained discrepancies. Out of specification results on multiple batches of tablets

Qvents
July 13, 2023