FDA 483 - MSN Laboratories Private Limited - July 25, 2025

An FDA inspection conducted from July 21-25, 2025, at MSN Laboratories Private Limited, Unit-4, in Rangareddy, Telangana, India, identified significant issues related to drug manufacturing controls. The firm received an FDA Form 483, detailing two key observations. Firstly, the company failed to adequately verify the identity of each component used in drug products. Specifically, there was no specific identity analysis performed for every container of raw material, nor was a limit test for Be conducted as required. Furthermore, the firm's standard operating procedure for sampling, testing, and release of raw materials did not mandate sampling from each container of every received lot, indicating a critical lapse in quality control over incoming materials. Secondly, the inspection revealed a lack of appropriate controls over computer and related systems. The company utilized shared usernames and passwords for various Human Mechanical Interface (HMI) systems involved in drug product manufacturing, including those for products shipped to the US market. Additionally, some instruments used for in-process testing during tablet and capsule production lacked any username or password assignment, compromising data integrity and restricting authorized personnel access. These observations highlight potential non-compliance with current Good Manufacturing Practices (cGMP) regulations. While an FDA Form 483 does not represent a final agency determination, MSN Laboratories is expected to address these findings by developing and implementing robust corrective actions to ensure drug product quality, safety, and data security. The firm should provide a detailed response to the FDA outlining their remediation plans.