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
SCYNEXIS recalled 2 lots of Brexafemme (ibrexafungerp) tablets in U.S. due to potential cross contamination
Centaur India formulation facility at Pune, Maharashtra, India was issued Warning letter by FDA citing
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
Medgel, India was issued a Warning letter by USFDA in July 2023. Deficiencies include inadequate
