Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Indoco Remedies’ Goa Plant (FEI 3005124189) received a warning letter from the FDA following critical
As expected FDA has taken regulatory action and issued a Warning letter to Natco, following
FDA inspected the Drug Testing Establishment of DRL (Dr.Reddy’s Laboratories) at Bachupally, Telengana India (FEI:3009483004)
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)
Dr.Reddys Laboratories (DRL) Medchal, Telengana site was inspected by USFDA (Investigators Saleem A Akhtar &
The Warning letter (dated November 17, 2023) follows the FDA inspection at Cipla’s Pithampur, Indore
Cipla in a statement informed that its Pithampur, Indore facility is issued an USFDA Warning
