Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)
USFDA issued a Warning letter to Intas, Matoda, Ahmedabad facility (FEI 3003157498) on 21 November
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
