FDA EIR - MSN Laboratories Private Limited, Unit-II - May 25, 2018

An FDA Good Manufacturing Practice (GMP) inspection of MSN Laboratories Private Limited, Unit II, an Active Pharmaceutical Ingredient (API) manufacturer located in Patancheru, Telangana, India, took place from May 21 to May 25, 2018. The inspection was conducted under Compliance Program 7356.002F for API manufacturing and adhered to the ICH-Q7 guideline, covering the company’s Quality, Production, Material, and Facilities and Equipment systems. This was part of the FY2018 Foreign Drug Inspection initiative. Notably, the inspection concluded without the issuance of an FDA-483 document, which lists formal inspectional observations or potential violations. Although a single verbal observation was discussed with the company's management during the exit meeting, it did not result in a written deficiency or a requirement for the firm to implement specific corrective actions based on this report. The FDA classified the inspection outcome as "No Action Indicated (NAI)," signifying that no significant regulatory non-compliance was observed that warranted formal enforcement. The report internally recommended a re-inspection as per the Center for Drug Evaluation and Research (CDER) risk assessment.