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Dr Reddy's Facility Cleared by USFDA
5 Mar
Summary
- USFDA inspection of Dr Reddy's Srikakulam facility classified as VAI.
- Establishment Inspection Report (EIR) issued, closing the inspection.
- US SEC concluded its probe into alleged improper payments without action.
Dr Reddy's Laboratories reported on March 5, 2026, that the U.S. Food and Drug Administration (USFDA) has closed its inspection of the company's formulations manufacturing facility in Srikakulam, Andhra Pradesh. The inspection, conducted as a Good Manufacturing Practice (GMP) and Pre-Approval Inspection (PAI), was classified as 'Voluntary Action Indicated' (VAI).
The company received the Establishment Inspection Report (EIR) on March 4, 2026. An EIR signifies the FDA's official determination of a facility's GMP compliance. A VAI classification indicates that while some violations were observed, they do not necessitate further regulatory enforcement, with improvements being voluntary.
In related news, the U.S. Securities and Exchange Commission (SEC) recently concluded its probe into allegations of improper payments by Dr Reddy's Laboratories. The SEC stated it does not intend to recommend enforcement action at this time regarding the investigation, which began in November 2020.
