Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
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
Catalent USFDA 483 /Bloomington (FEI :3005949964)/ Inspection Dates: May 4-12, 2023 / Inspectors: Wayne Scifert,
Accord USA has initiated recall of multiple lots of Atropine Sulfate, USP 8 mg per
IPCA Dhar facility was inspected by USFDA in June 2023. The site (FEI 3007574780) was
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
USFDA Inspected IPCA (Ratlam, India) site in June 2023, Inspectors – Rajiv R Srivastava, Salim
IPCA Ratlam (India) was issued USFDA 483 with 11 observations after inspection in June 2023
Aurobindo Unit 1 (FEI 3004021253) was inspected by USFDA investigator Rita K Kabaso from August
