Dr. Reddy’s Laboratories has announced the outcome of a recent GMP inspection by the United States Food & Drug Administration (USFDA) at its API manufacturing facility in Mirfield, United Kingdom. The USFDA has classified the inspection as ‘Voluntary Action Indicated (VAI)’, signifying a favorable regulatory status and closing the inspection as officially completed under relevant guidelines.
USFDA Inspection Outcome Clarified
Dr. Reddy’s Laboratories Limited has provided an update regarding a Good Manufacturing Practices (GMP) inspection conducted by the United States Food & Drug Administration (USFDA). The inspection took place at the company’s Active Pharmaceutical Ingredient (API) manufacturing facility located in Mirfield, West Yorkshire, United Kingdom.
‘Voluntary Action Indicated’ Classification
The company announced that the USFDA has officially classified the outcome of this inspection as ‘Voluntary Action Indicated (VAI)’. This classification is a positive regulatory designation. Furthermore, the USFDA has confirmed that the inspection is now officially closed under the provisions of 21 CFR 20.64(d)(3).
This clarification is for the information and records of stakeholders, marking a significant positive development in the company’s regulatory compliance and operational standing.
Source: BSE
