Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA Inspected UCB Farchim site at Bulle, Switzerland (FEI 3005023799) in June / July 2023.
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.
Panacea Biotec, Baddi facility was inspected by USFDA in Oct 2023- investigators Sandra A Boyd
Spectrum Laboratories Inc, New Jersey, USA (FEI 2246824) was inspected by FDA investigators Sayyem H
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Biocon Malaysia was inspected by USFDA Investigators Eileen A. Liu, Patty P. Kaewussdangkul, Daniel Lahar,
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
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
