FDA EIR - Glenmark Life Sciences Limited - July 05, 2019

An FDA inspection was conducted at Glenmark Life Sciences Limited, located in Ankleshwar, India, from July 1 to July 5, 2019. This inspection, part of the CDER IOG Work-plan for FY19, focused on the company's compliance with Current Good Manufacturing Practices (cGMP) for Active Pharmaceutical Ingredients (API), adhering to Compliance Program 7356.002F and ICH Q7 guidelines. The inspection covered quality, production, facility, equipment, and laboratory systems. At the conclusion of the inspection, the FDA issued an FDA-483, detailing several significant observations. These included inadequate comprehensive investigations to determine the root cause of impurities, deficiencies in personnel training, incomplete batch record instructions, and insufficient control systems to prevent cross-contamination within the facility. The inspection resulted in a "Voluntary Action Indicated" (VAI) classification, meaning the FDA identified objectionable conditions that require corrective actions by the company, though immediate regulatory enforcement was not pursued. A routine re-inspection has been recommended to verify the implementation of these necessary improvements. This inspection followed a previous review in December 2016, which also received a VAI classification, with prior corrective actions deemed adequate.