Warning letters, 483s, Recalls, Import Alerts, Audit observations
USFDA inspection of Cipla, Patalganga site manufacturing APIs and Tablets resulted in USFDA 483 with
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
Chinese API Manufacturer Sichuan Deebio Pharmaceuticals was awarded USFDA 483 with six observations citing Data
Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA
Aurobindo arm Eugia Pharma site at Sangareddy, Telengana was inspected by USFDA in Jan -Feb
The USFDA 483 issued to Sichuan Deebio Pharmaceutical Co. Ltd cite critical data integrity observations
Laurus, Visakh was issued USFDA 483 with five (5) observations following USFDA inspection by investigators
