Warning letters, 483s, Recalls, Import Alerts, Audit observations
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation received an USFDA 483 for critical cGMP deviations.
Indoco Remedies’ Goa Plant received a warning letter from the FDA following critical observations during
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility on 21 November 2023. This
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd
