Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
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
Accord healthcare recalled from US market Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial
USFDA Warning letter to Dupont cites inadequate evaluation of complaints, even though the Firm received several
USFDA Warning letter to Dupont cites inadequate OOS investigations, Root cause and CAPA, Impact evaluation. The warning letter
