MSN Laboratories Private Limited – FDA 483, Dec 11, 2025

MSN Laboratories Private Limited (Unit-05), a sterile manufacturer located in Telangana, India, was inspected by the FDA from December 5 to December 11, 2025. The resulting report identifies five significant areas of concern regarding the facility"s manufacturing and quality control standards. Key violations include a failure to perform performance studies on equipment critical to product safety and integrity, such as labeling systems and integrity testers. Additionally, the facility accepted raw materials based on supplier reports without conducting independent tests for impurities. The Quality Unit also failed to ensure drug products met official standards, approving and releasing batches with incorrect pH specifications. Further issues were noted in environmental monitoring, where air samplers were placed in low-risk areas rather than at locations representing the highest risk to product sterility. The facility also lacked established alert limits for microbial contamination and utilized an inadequate sampling plan for visual inspections that could not guarantee batches were free of visible particles. While these findings are not a final determination of non-compliance, the company is required to respond to the FDA with detailed corrective actions or objections to address these systemic deficiencies in their quality management system.