Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA
The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with
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
Sun Pharma Dadra unit (FEI 3004561553) was inspected by USFDA in December 2023 by FDA
The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by
USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in
USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites
