FDA EIR - Strides Alathur Private Limited - April 05, 2024

An FDA inspection of Strides Alathur Private Limited, a manufacturer of non-sterile human and animal drug tablets and capsules, was conducted from April 1 to April 5, 2024. This comprehensive cGMP inspection covered quality, production, laboratory, and facilities and equipment systems, adhering to Compliance Programs 7356.002 for drug manufacturing and 7371.001 for animal drug manufacturing. During the inspection, two significant deficiencies were identified and documented on a Form FD 483, issued to Mr. Umesh P. Kale, Chief Quality Officer. Firstly, the company's control records, including deviations and market complaints, demonstrated insufficient investigation into unexplained discrepancies. Secondly, the Document Control System was found to be inadequate for timely and accurate replication of electronic records outside its primary system. Management was informed that these observations could potentially be deemed violations of the Federal Food, Drug, and Cosmetic Act, which might lead to legal sanctions, including product detention or refusal of entry into the United States. Strides Alathur Private Limited acknowledged the findings and committed to submitting a formal response addressing the observations within fifteen business days. The inspection concluded with a "Voluntary Action Indicated" classification, suggesting that the firm is expected to voluntarily correct the issues.