Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a notification on 22 May, 2025 on Data Integrity concerns on reliability
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
Intas facility was inspected by FDA investigators Jose E Melendez, Justin A Boyd, Pratik S
USFDA483 to Intas cites manipulated visual inspection reports; failure to characterise particles observed in injection
