Warning letters, 483s, Recalls, Import Alerts, Audit observations
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
USFDA Inspection at Cadila Ahmedabad, India in April-May 2019 by Investigators Justin A Boyd, Thomas
Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August
Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August
Potential contamination of drug products with Diethylene Glycol(DEG), Ethylene Glycol(EG) has severe consequences including fatality
USFDA Warning letter to Glenmark cites deficiencies in Out of specification (OOS) investigations, firms response to
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
