Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
USFDA Warning letter to Dupont cites failure to ensure test methods are suitable, use of Non
USFDA Warning letter to Dupont cites inadequate change management program. The warning letter to Dupont Nutrition USA in
USFDA Warning letter to Dupont, USA cites inadequate laboratory controls, integrity of data and quality system does
USFDA Warning letter to Centrient India (Toansa, Punjab FEI 3004497364) in December 2022 cited inadequate
