Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. FDA has issued a Warning Letter to Simtra BioPharma Solutions following cGMP deviations
USFDA Inspection of Pharmathen’s Rodopi facility in Greece (FEI 3009961173) resulted in issuance of Form
FDA has published the USFDA Form 483 issued to sterile drug manufacturing facility of Fareva
In September 2025, the USFDA classified Sun Pharmaceutical Industries Ltd.’s Halol facility as OAI (Official
Indian API manufacturer Global Calcium Pvt Ltd was issued a Warning letter by USFDA in
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection
Following the USFDA 483 issued in April 2024 and the OAI classification in July 2024,
The Eugia facility in Bhiwadi, Rajasthan, India (FEI 3009883410) was recently classified as OAI (Official
Zydus Pharmaceuticals (USA) Inc initiated recall of multiple lots of Verapamil Hydrochloride injection due to
Zydus Jarod facility (FEI 3013712903) is classified OAI by USFDA in July 2024. The USFDA
