Supriya Lifescience Ltd. has successfully concluded a recent inspection by the U.S. Food and Drug Administration (USFDA) at its manufacturing facility in Lote, Maharashtra. The inspection, conducted from February 2 to February 6, 2026, resulted in a single minor observation. The company has since addressed this finding, receiving an Establishment Inspection Report (EIR) with a status of Voluntary Action Indicated (VAI), confirming the successful completion of the regulatory audit.
Successful Regulatory Audit
Supriya Lifescience Ltd. has announced the successful completion of a quality audit by the U.S. Food and Drug Administration (USFDA) at its manufacturing plant situated in the Lote, Parshuram Industrial Area, Maharashtra. The audit was carried out over five days, between February 2, 2026, and February 6, 2026.
Inspection Findings and Resolution
Following the review, the regulatory authority issued a Form 483, which highlighted one (1) minor observation. In response, the company took proactive measures to address the finding, ensuring alignment with global quality standards. Consequently, the company has received the Establishment Inspection Report (EIR), which carries a Voluntary Action Indicated (VAI) classification, officially marking the successful closure of the inspection process.
Commitment to Quality Standards
The company maintains its dedication to upholding current Good Manufacturing Practice (cGMP) standards. This successful inspection outcome reinforces the operational excellence and quality management systems currently in place across the company’s manufacturing network.
Source: BSE