Warning letters, 483s, Recalls, Import Alerts, Audit observations
The USFDA inspection of Hetero Labs Ltd, Unit-IX (FEI: 3009093782), Narasapuram, India, conducted in September
USFDA issued a Warning letter to Glenmark Facility at Pithampur (FEI 3008565058) in July 2025.
USFDA has issued a Warning letter to Glenmark Pharma’s Pithampur manufacturing facility (FEI 3008565058). The
USFDA 483 issued to Glenmark Pharma’s Pithampur facility (FEI: 3008565058) in India flagged critical deviations
In March 2025, Glenmark initiated recall of 23 products (148 lots) in US for cGMP
Authored by: Venkiteswaran.T.K, Subrangshu Chourdhary, Srinivas Churya Jubilant Generics Roorkee facility was inspected in January
Cipla facility at Verna, Goa was audited by USFDA during June 2024 ending with issuance
USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
