FDA EIR - MSN Laboratories Private Ltd. - December 20, 2019

An FDA cGMP and Post-Approval inspection of MSN Laboratories Private Ltd., an Active Pharmaceutical Ingredient (API) manufacturer located in Rudraram Village, Telangana, India, was conducted from December 16 to December 20, 2019. This routine surveillance inspection, part of the Division of Pharmaceutical Quality Inspection's work plan, followed compliance programs for API process inspections and post-approval audits, utilizing ICH Q7 as a guiding document. The inspection comprehensively covered the firm's Quality, Materials, Production, and Laboratory Control systems, including a post-approval audit for several Drug Master Files (DMFs) approved for the U.S. market, and one pending approval. Notably, the inspection also verified corrective actions taken by MSN Laboratories in response to two observations from a previous FDA inspection in March 2018, finding those corrections adequate. Crucially, the current inspection identified no major objectionable conditions. Consequently, no FDA-483 observations were issued to the firm at the close of the inspection, and no samples were collected. The inspection concluded with a "No Action Indicated (NAI)" classification, reflecting satisfactory compliance with regulatory standards. Therefore, no specific regulatory actions were required from MSN Laboratories following this review.