Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA
Intas facility at Matoda, Sanand in India (FEIÂ 3004011473) was inspected by FDA investigators Jose E
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
FDA published the USFDA483 issued to Intas site (FEI 3003157498) in Ahmedabad, India after inspection
USFDA Inspection at Cadila Ahmedabad, India in April-May 2019 by Investigators Justin A Boyd, Thomas
USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Chromatographic integration and
USFDA 483 to Sunpharma, Mohali unit in Aug 2022 cites deficiencies in Product Quality Reviews
