Unichem Laboratories Limited on Wednesday announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Pithampur API facility. The inspection, which was conducted from February 24 to February 28, 2025, has been classified as Voluntary Action Initiated (VAI).
The update was shared through an exchange filing under Regulation 30 of SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company had earlier disclosed the inspection in its March 1, 2025, communication to stock exchanges.
A VAI classification indicates that although the USFDA observed certain objectionable conditions, it does not intend to take or recommend any administrative or regulatory action.
This development is seen as a positive regulatory milestone for Unichem, as receipt of the EIR confirms closure of the inspection cycle for the Pithampur unit without major compliance hurdles.
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