Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA inspected Granules India’s Finished Dosage and PFI facility (FEI 3004097901) at Gagillapur Village, Hyderabad
With contributions from: Venkiteswaran.T.K; Satish Reddy; Shashank Sharma; Srinivas Churya; Subrangshu Choudhary, Veena Raj The USFDA Form
Sun Pharma’s Dadra Unit was issued FDA Warning letter in June 2024, following critical observations
Sun Pharma Dadra unit was inspected by USFDA in December 2023 by FDA investigator Pratik
The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
Dr.Reddy’s Laboraties (DRL) site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S
The DRL site was inspected by USFDA (Investigators Saleem A Akhtar & Pratik S Upadhyay)
Intas facility was inspected by FDA investigators Jose E Melendez, Justin A Boyd, Pratik S
USFDA Inspection of Intas, Matoda, Sanand facility in India (FEI 3004011473); from 22 November 2022 to
