FDA 483 - Kindeva Drug Delivery LP - November 13, 2025

During an inspection conducted from November 3 to November 13, 2025, the FDA issued a Form 483 to Kindeva Drug Delivery L.P. The observations highlight significant deficiencies in manufacturing process controls and quality system documentation. The first observation details a lack of adequate control procedures to monitor manufacturing processes and validate their performance, particularly concerning Critical Control Points (CCPs). The company's manufacturing equipment lacks continuous automated monitoring, real-time alarm capabilities, and data recording for critical parameters, with reliance on periodic manual checks deemed insufficient to detect deviations. This affects a substantial volume of product manufacturing monthly. The second observation notes a failure to investigate and document discrepancies in the microbial testing method for water used in equipment cleaning. Inspectors observed systematic deficiencies in the testing apparatus that could compromise the reliability of test results, yet no formal investigation or corrective action was documented. This prevents the verification of water quality against established specifications, critical for equipment cleanliness and product integrity. These observations indicate that Kindeva Drug Delivery L.P. must implement robust corrective and preventive actions to ensure compliance with good manufacturing practices, specifically by enhancing process monitoring and control systems and establishing a comprehensive discrepancy investigation and documentation process, as required by the Federal Food, Drug and Cosmetic Act.