Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
The USFDA has issued a Warning Letter to Hyderabad-based OTC manufacturer Akron Formulations for critical
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
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
USFDA Warning letter to Australian API manufacturer cites basic laboratory compliance issues – Inadequate OOS
USFDA has updated Safety Communication on Chinese made plastic syringes. FDA had issued a Safety
FDA issued a Warning letter to Amman Pharmaceuticals following inspection at the facility (FEI 3013501887)
