Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
USFDA 483 to UCB Belgium cites fundamental gaps in document control  – uncontrolled forms for
USFDA 483 to IPCA, Silvassa (April 2023) cites Failure of Quality Unit, Failure of Quality
USFDA 483 to IPCA, Silvassa (April 2023) cites lapses in timely closure of failure investigations
