FDA 483 - Dr. Reddy's Laboratories Ltd. - May 12, 2023

Between May 8 and May 12, 2023, the FDA conducted an inspection of Dr. Reddy's Laboratory, Unit-2, located in Srikakulam, Andhra Pradesh. The evaluation, performed under the regulatory framework of Section 704(b) of the Federal Food, Drug, and Cosmetic Act, identified several significant manufacturing and quality control violations. Key issues included the failure to install and qualify commercial packaging and labeling equipment in the production block. Inspectors also observed that equipment documented as clean actually contained visible white particles and brown stains, and many units lacked the barcode labels necessary for tracking cleaning status in the electronic record system. Further operational deficiencies were noted in the dispensing area, where scales were improperly leveled and suffered from wireless connectivity failures that disrupted operations. Additionally, laboratory controls were found to be insufficient; the firm utilized unvalidated test methods for product release and failed to perform required performance verification tests on dissolution apparatus. As these are preliminary inspectional observations, the company is required to submit a formal response to the FDA. This response must include a detailed plan for corrective actions or provide justifications for the observed conditions to ensure future compliance with drug manufacturing standards.