Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA has published the USFDA Form 483 issued to Novo Nordisk API manufacturing facility at
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 had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site
Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven
USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.
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
USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,
USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in
