Zydus Lifesciences has received an Establishment Inspection Report (EIR) from the USFDA for its SEZ II manufacturing facility in Ahmedabad. The USFDA conducted a Pre-Approval Inspection (PAI) at the facility from August 11th to 14th, 2025, which has now been concluded. The inspection resulted in NIL observations, and the facility is classified as No Action Indicated (NAI).
USFDA Inspection Concluded
Zydus Lifesciences announced that the USFDA had completed its inspection of the group’s manufacturing plant located in SEZ – II, Ahmedabad. The inspection took place between August 11th and 14th, 2025. This was a Pre-Approval Inspection (PAI) by the USFDA.
Outcome of the Inspection
The USFDA has concluded the inspection, and the outcome was that the inspection concluded with NIL observations. Following the inspection, the USFDA has classified the facility as No Action Indicated (NAI).
Source: BSE
