Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
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 / IPCA Laboratories, Silvassa, India / FEI 3005977675/ USFDA Investigators: Rajiv Srivastava, Kellia
