USFDA Closes Dr Reddy's UK API Plant Inspection With VAI Classification
Hyderabad: The United States Food and Drug Administration (USFDA) has classified the outcome of its Good Manufacturing Practices (GMP) inspection at Dr. Reddy's Laboratories Limited's API manufacturing facility in Mirfield, West Yorkshire, United Kingdom, as 'Voluntary Action Indicated (VAI)' and has officially closed the inspection.
The company said the latest development relates to its earlier intimation dated September 8, 2025, through which it had informed the stock exchanges about the GMP inspection conducted by the USFDA at its API manufacturing facility located in Mirfield, West Yorkshire, UK.
Following the inspection, the USFDA has now classified the inspection outcome as Voluntary Action Indicated (VAI). The regulator has also concluded that the inspection is officially closed under 21 CFR 20.64(d)(3).
The latest development confirms that the USFDA has closed the GMP inspection conducted at Dr. Reddy’s API manufacturing facility in Mirfield, West Yorkshire, after classifying its outcome as Voluntary Action Indicated (VAI) under the applicable regulatory framework.
