Dr. Reddy’s Laboratories has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for its Active Pharmaceutical Ingredient (API) manufacturing facility (CTO-2) in Bollaram, Hyderabad. The inspection, conducted previously, has now been classified as “Voluntary Action Indicated” (VAI), signifying that the USFDA has concluded the inspection without recommending any further regulatory or enforcement action.
In an exchange filing, Dr. Reddy’s Laboratories confirmed that the inspection is now officially closed under 21 CFR 20.64(d)(3). This classification suggests that while there may have been minor observations, they do not warrant any significant regulatory concerns.
This latest regulatory update brings a positive development for Dr. Reddy’s Laboratories as it ensures continued operations at the Bollaram API facility without any compliance-related restrictions. The successful completion of the USFDA inspection supports the company’s commitment to maintaining high manufacturing standards and regulatory compliance for its global pharmaceutical operations.
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