Warning letters, 483s, Recalls, Import Alerts, Audit observations
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore
USFDA Inspected Indian drug manufacturer Kilitch facility in Mumbai (FEI 3011853060) in Oct 2023. USFDA
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
USFDA 483 / UCB Farchim SA/ June 2023 / Gaps in Data Integrity program, lack
USFDA 483 issued to UCB Farchim SA, Switzerland site (FEI 3005023799) is published by FDA.
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
Related Links Warning letter Intas Warning letter Centaur Warning letter Medgel Warning letter Baxter Intas
Intas facility at Matoda, Sanand in India (FEIÂ 3004011473) was inspected by FDA investigators Jose E
USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection
