Shilpa Pharma Lifesciences Limited – FDA EIR, Mar 14, 2025

An FDA surveillance inspection of Shilpa Pharma Lifesciences Limited, an active pharmaceutical ingredient (API) manufacturer located in Chicksugur, India, was conducted from March 10 to March 14, 2025. This inspection aimed to assess the firm's compliance with Current Good Manufacturing Practices (CGMP) for APIs intended for human drug products marketed in the U.S. The inspection was carried out under Compliance Program 7356.002F, specifically for Active Pharmaceutical Ingredient Process Inspection, with reference to ICH Q7 guidance. The scope encompassed quality, materials, production, facilities and equipment, and laboratory control systems. At the conclusion of the inspection, no formal Form FDA 483, Inspectional Observations, was issued. However, one verbal observation was discussed with the firm. This pertained to an inconsistency in CGMP logbooks, such as the warehouse storage temperature logbook, which lacked a dedicated column for Quality Assurance verification to confirm documented data review. Despite this verbal observation, the inspection was officially classified as "No Action Indicated" (NAI) by the district. The report recommends a re-inspection based on future CDER risk assessment and the SSIL plan, but no immediate regulatory actions were required. The company's registration remains current until December 2025.