Warning letters, 483s, Recalls, Import Alerts, Audit observations
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
Natco Pharma (india) Kothur facility was inspected by USFDA (Investigators Pratik S. Upadhyay and Saleem
Natco Pharma (india) Kothur facility was inspected by USFDA in October 2023. The site (FEI
IPCA unit at Dhar, Madhya Pradesh, India USFDA 483 cites Invalidation of OOS with inconclusive
