Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and
Nectar Lifesciences was issued an Untitled letter (UL) by USFDA in Sep 23 citing deficiencies
In a communique Biocon stated USFDA has categorised inspection classification for Biocon Malaysia as OAI
USFDA announced it has awarded 10 new clinical trial studies through Orphan Products Grants Program
USFDA has eliminated the REMS for Lotronex (alosetron hydrochloride) and approved generics. Alosetron hydrochloride is
As per the GDUFA III commitment letter, USFDA has issued a draft guidance for facilities
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
USFDA: Recommended Acceptable Intake Limits for Nitrosamine Drug Substance[1]Related Impurities (NDSRIs) – Guidance for Industry
The Warning letter cite Failure of Quality unit in ensuring cGMP compliance, Inadequate control over
