Warning letters, 483s, Recalls, Import Alerts, Audit observations
The U.S. Food and Drug Administration (FDA) issued a Warning Letter to Aspen Biopharma Labs
The U.S. FDA issued a warning letter to International Laboratories Corp. (FEI 3006403166) following CGMP
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
Authored by: Venkiteswaran.T.K, Srinivas Churya FDA has published the Warning Letter issued to the Viatris Pithampur facility in December
New Delhi based Unexo Life Sciences has initiated a major recall of several medicated patch
USFDA inspected Granules India’s Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad
Accord Healthcare Inc, US is recalling one lot of Cisplatin injection due to failed impurities.
Five different facilities of Eugia across India and US were inspected by USFDA between December
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary The USFDA inspection
