Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva
Pune based Akriti Pharmaceuticals Private Limited’s EUGMP Certificate remains suspended as the facility remains in
Granules India received a warning letter from the USFDA in February 2025. This was along
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch
Chinese OTC Manufacturer Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd was inspected by USFDA in March
USFDA inspected Granules India’s Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad
Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations
USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Laurus Synthesis was issued an Untitled Letter by USFDA in May 2024, following critical observations
