FDA 483 - Strides Pharma Science Limited - May 20, 2026

During an FDA inspection from May 12 to May 20, 2026, several significant manufacturing and quality control deficiencies were identified at the Strides Pharma Science Ltd. facility in Bangalore, India. The observations highlight failures in adhering to professional manufacturing standards intended to ensure drug safety and purity. Key issues included the use of unvalidated laboratory methods for identifying microorganisms and a lack of investigations into test results that exceeded safety thresholds. Data integrity was a major concern, as the company granted analysts excessive software permissions to modify test results and failed to retain electronic audit trails for the required duration; specifically, records were deleted after one year despite products having a five-year shelf life. Physical inspections also revealed inadequate cleaning practices, with residues and leftover medicine from previous batches found on equipment marked as "cleaned." Furthermore, the facility lacked controls to prevent the use of unauthorized production recipes and failed to conduct mandatory purity testing on high-risk ingredients used in medicines for the United States market. Under the regulatory framework for human drug manufacturing, Strides Pharma is expected to provide a formal response to the FDA. This response must detail specific corrective actions to validate laboratory procedures, enhance data security, improve equipment sanitation, and ensure thorough testing of all drug components to prevent contamination and ensure product quality.