Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
USFDA 483 to Lupin Pithampur in Mar 2023 (Inspectors Eileen A Liu, Yvins Dezan) cites deficiencies
USFDA inspection of Cipla Pithampur site ( FEI 3008581988) by Inspectors Saleem A Akhtar &
USFDA Inspection of Intas, Matoda, Sanand facility in India (FEI 3004011473); from 22 November 2022 to
Macleods recalled 10052 bottles of Levofloxacin USP 500mg tablets in January 2023 due to mismatching
USFDA Warning letter to Glenmark cites deficiencies in Out of specification (OOS) investigations, firms response to
