Category: USFDA 483

FDA 483 to DRL : Issues in Analytical Va

USFDA 483 issued to Dr.Reddys (DRL) API unit in Pydibhimavaram, India cites failure to validate

Data Integrity issues, Delayed records:

USFDA had inspected the Jiangsu Hengrui Pharma’s Huanghe road site in January 2024. The site

Eugia USFDA 483 Cites Inadequate Contain

Aurobindo arm, Eugia Pharma Specialities facility at Bhiwadi, Rajasthan was issued USFDA 483 with seven

Zydus Vadodara USFDA 483 cites Contamina

USFDA inspection of Zydus Life sciences, Vadodara facility resulted in USFDA 483 with 10 observations.

USFDA 483 to Sun Pharma points to lack o

The USFDA 483 issued to Sun Pharma, Dadra unit in India (FEI 3004561553) published by

FDA Warning letter to Natco over Cleanin

As expected FDA has taken regulatory action and issued a Warning letter to Natco, following

FDA 483 to Jubilant : Data Integrity con

USFDA inspected Jubilant Generics Limited facility in Roorkee, India, from January 25th to February 2nd,

USFDA 483 to Eugia Polepally unit cites

USFDA had inspected Aurobindo’s Eugia SEZ Pvt Ltd facility at Polepally, Telengana in India in

One more Eugia facility hit with USFDA 4

Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA

FDA 483 to Chinese API Manufacturer Sich

The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations