Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA has classified Sun Pharma’s Baska (Halol) facility (FEI: 3002957541) as Official Action Indicated
An USFDA 483 to CDMO major Catalent’s Baltimore facility (FEI 3015558590) in US cite poor
The USFDA has escalated the OAI (Official Action Indicated) classification of the Novo Nordisk–owned Catalent
Janssen Vaccines Corp., a Johnson & Johnson company operating in Korea, was issued an FDA
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
The U.S. Food and Drug Administration (FDA) has issued a Warning Letter in June 2025
The USFDA issued a warning letter in January 2025 to Sanofi’s API facility in Framingham,
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
In May 2023 several Injectable products manufactured by Indian Contract Manufacturer Astral SteriTech Pvt. Ltd
