Warning letters, 483s, Recalls, Import Alerts, Audit observations
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
Novo Nordisk owned Catalent Indiana sterile products formulation facility was inspected by USFDA in June
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The Eugia facility in Bhiwadi, Rajasthan, India (FEI 3009883410) was recently classified as OAI (Official
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance
Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven
