One more Eugia facility hit with USFDA 483

Aurobindo’s Eugia SEZ Pvt. Ltd at Polepally Village, Mehaboob Nagar, Telengana was inspected by USFDA during 19-29th February 2024. Post inspection the facility was issued USFDA 483 with seven observations. Aurobindo in a press statement to stock exchanges declared that the observations are procedural in nature and will be responded to in time.

The USFDA inspection and 483s for the Mehaboob Nagar facility (FEI 3011905047) comes close on the heels of the FDA inspections at Eugia US Manufacturing in New Jersey (FEI 3015534630) in December 2023 and Eugia Pharma Specialities Limited (FEI 3008461619), Sangareddy, Telengana facility in Janurary 2024. Following critical observations Eugia had halted manufacturing in certain lines at the Sangareddy facility (FEI 3008461619) in February 2024. However Eugia is restarting the production in the aseptic lines at the facility in March 2024.

Eugia USFDA Registered sites