Dr. Reddy’s Laboratories has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its API manufacturing facility (CTO 5) in Miryalaguda, Telangana. The EIR was issued on August 7, 2025, following a GMP inspection that was earlier conducted and disclosed by the company on May 24, 2025.
The USFDA has classified the outcome of the inspection as ‘Voluntary Action Indicated (VAI)’, meaning the agency has closed the inspection with some observations, but no further regulatory action is anticipated at this time. The inspection is officially considered closed under 21 CFR 20.64(d)(3).
A VAI classification typically indicates that the facility remains compliant for continued supply to the US market. This update should bring some regulatory clarity and comfort to stakeholders and investors.
