FDA 483 - MSN Pharmachem Private Limited - April 21, 2023

MSN Pharmachem Private Limited, an API manufacturer in Patancheru, India, was cited for deficiencies in its quality unit's written procedures and their adherence. The inspection revealed issues with market complaint investigations, including inadequate scientific justification for OOS results and failure to request customer samples, as well as a lack of written procedures for trending both regular and temporary change controls, and a failure to close minor change controls within the specified timeframe. These observations indicate a systemic weakness in the firm's quality management system.