FDA EIR - MSN Laboratories Private Limited, R&D Center - June 14, 2018

An FDA cGMP surveillance inspection was conducted at MSN Laboratories Private Limited's R&D Center in Sangareddy District, Telangana, India, from June 12-14, 2018. This inspection, carried out under the "Drug Manufacturing Inspections" program, covered quality, facility & equipment, and laboratory control systems. The R&D Center functions as a dedicated facility for developing manufacturing processes and analytical methods for active pharmaceutical ingredients (APIs) and finished drug products for the broader MSN Group.

This visit served as a follow-up to a previous inspection in 2015, which resulted in a Form FDA-483 with three observations. These included deficiencies in method validation for polymorphic identification using a Powder X-Ray Diffractometer (PXRD), inadequate sample registration procedures, and a lack of proper review and approval of validation documents by the quality control unit.

During the 2018 inspection, all previously identified issues were found to be corrected. The site had ceased PXRD and Ion Chromatography release testing, transferring these activities to API manufacturing sites. Sample log books were updated to record receipt dates and times, and the Development Quality Assurance unit was observed to be properly reviewing and approving validation materials. Consequently, no new Form FDA-483, Inspectional Observations, was issued to the firm, indicating no objectionable conditions were found.

A key discussion point with management was the absence of a formal complaint procedure for laboratory testing services provided to other MSN Group facilities. Management acknowledged this gap and committed to developing and implementing such a procedure. Overall, the inspection concluded positively, with the firm demonstrating resolution of past issues and a commitment to address minor procedural enhancements.