USFDA classifies Dr. Reddy’s Laboratories Srikakulam unit
Key Highlights
The USFDA assigned a Voluntary Action Indicated classification to the Dr. Reddy’s Laboratories facility in Srikakulam after a recent inspection.
The United States Food & Drug Administration has assigned a Voluntary Action Indicated classification to the Dr. Reddy’s Laboratories facility in Srikakulam. This status follows the completion of a recent inspection at the Andhra Pradesh unit by the American health regulator, which has now officially closed its review of the site.
The USFDA conducted both a Pre-Approval Inspection and a Good Manufacturing Practices inspection at the FTO-SEZ Process Unit-02. Following this review, the agency officially closed the inspection process for the site. The company operates this unit as part of its broader pharmaceutical manufacturing network based in Hyderabad, Telangana. It produces and sells various medicinal products for domestic and international markets.
According to the guidelines provided by the US health regulator, the VAI classification indicates that inspectors observed certain conditions or practices during their visit. However, the agency stated it is not recommending or taking any regulatory or administrative action against the company at this time. The regulator confirmed that the inspection outcome for the facility is now officially closed.
Based on company and agency reports. For information only; not investment advice.