Dr. Reddy’s Laboratories has announced an important update regarding its formulations manufacturing facility, FTO 11, located in Srikakulam, Andhra Pradesh, India. Following a Good Manufacturing Practices (GMP) and Pre-Approval Inspection (PAI) conducted by the United States Food & Drug Administration (USFDA), the company has now received the Establishment Inspection Report (EIR) on October 20, 2025.
The USFDA classified the inspection outcome as “Voluntary Action Indicated (VAI)”, confirming that the inspection has been officially closed under the provisions of 21 CFR 20.64(d)(3). This classification signals that while minor issues were noted, there are no major compliance violations affecting the facility’s operations.
Dr. Reddy’s Laboratories continues to maintain strict adherence to global quality and safety standards, ensuring that its manufacturing practices meet international regulatory expectations. The company remains committed to providing high-quality pharmaceutical products to patients worldwide.
