Warning letters, 483s, Recalls, Import Alerts, Audit observations
Janssen’s Korean Vaccine unit Janssen Vaccines Corporation (FEI 3012637764) received an USFDA 483 for critical
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,
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
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
Eugia US LLC is recalling one lot of Methocarbamol Injection in US for white particles
USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in
