Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA 483 to UCB Belgium cites fundamental gaps in document control  – uncontrolled forms for
USFDA 483 to IPCA, Silvassa (April 2023) cites Failure of Quality Unit, Failure of Quality
USFDA 483 to IPCA, Silvassa (April 2023) cites lapses in timely closure of failure investigations
USFDA 483 to IPCA, Silvassa (April 2023) cites inadequacies and thoroughness in Out of specification
Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality
USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Chromatographic integration and
USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Product Quality Reviews
USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites Data integrity issues and Backdating, records of
USFDA 483 to Lupin Pithampur cites deficiencies in Qualification and monitoring of equipment like HVAC
USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites deficiencies
