USFDA inspects Alkem Laboratories' Baddi manufacturing facility

USFDA had conducted an inspection at the Alkem Laboratories Limited manufacturing facility located at Baddi from 19th March, 2024 to 27th March, 2024. At the same time at the end of the inspection, the company received Form 483 with ten observations. This was a GMP as well as a Pre-Approval Inspection. There is no data integrity observation. This inspection is part of the routine business operations and the company shall submit to USFDA within the stipulated timeline, a detailed response to close out the said observations.

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant

USFDA has conducted an inspection at the SEZ Onco Injectable manufacturing plant of Zydus Lifesciences Limited at Ahmedabad. This cGMP USFDA inspection was conducted from March 18th to March 27th, 2024. The inspection closed with 4 observations. There were no data integrity related observations. The company will closely work with the USFDA to address the observations.