Other Events ·
USFDA classifies inspection of Srikakulam unit as Voluntary Action Indicated
RDYDR Reddys Laboratories Ltd
The USFDA has concluded its Pre-Approval Inspection and Good Manufacturing Practices review at Dr. Reddy's Laboratories' Process Unit-02 in Srikakulam, Andhra Pradesh, assigning a 'Voluntary Action Indicated' (VAI) outcome. This classification indicates minor deviations from regulatory standards that require corrective action but do not prevent approval or indicate imminent enforcement action. The inspection is now officially closed under 21 CFR 20.64(d)(3). Dr. Reddy's Laboratories Limited operates in the pharmaceutical industry, developing and manufacturing generic drugs, biosimilars, and active pharmaceutical ingredients.