Warning letters, 483s, Recalls, Import Alerts, Audit observations
Amidst the heightened surveillance and enforcement actions initiated by different state licensing authorities (state FDAs)
The USFDA issued a Warning letter to Hikal’s API facility in Jigani, Bangalore, India. The
Alembic recently initiated recall of antidepressant drug Doxepin Hydrochloride Capsules (10 mg) in US for Nitrosamine
The USFDA has issued a Warning Letter to Shiva Analyticals’ Bangalore facility following significant cGMP
USFDA issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.
Natco Pharma’s sterile products manufacturing facility at Rangareddy, Telengana (FEI 3004540906) was inspected by USFDA
First Recall of Diphenhydramine HCl for NDSRI With timelines closing in for drug product manufacturers
Piramal Pharma’s API unit at Navi Mumbai (FEI 3008763768) was issued USFDA Form 483 with
The FDA inspected Colgate-Palmolive/Tom’s of Maine, Inc’s Sanford facility in the US in May 2024.
Glenmark Pharmaceuticals is recalling several lots of the cardiovascular drug Carvedilol in US due to
