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
IPCA unit at Dhar, Madhya Pradesh, India USFDA 483 cites Invalidation of OOS with inconclusive
USFDA 483 to Intas cites lapses in investigation and review of failures and discrepancies in
USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim
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
