FDA EIR - Unichem Laboratories Ltd - February 21, 2020

An FDA surveillance inspection of Unichem Laboratories Ltd, located in Roha District Raigad, India, was conducted from February 17 to February 21, 2020. This inspection focused on the company's compliance with Good Manufacturing Practice (GMP) standards for active pharmaceutical ingredients (APIs), guided by Compliance Program 7356.002F and Q7 guidance for API manufacturing. The scope included the firm's quality, production, facilities and equipment, and laboratory systems related to non-sterile APIs produced by chemical synthesis. During the inspection, various records, including batch records, deviations, investigations, and stability data, were thoroughly reviewed. The regulatory assessment concluded with a "No Action Indicated (NAI)" classification, meaning no formal violations were observed that required a Form FDA-483. However, two verbal discussion items were raised with company management: batch record discrepancies and the impact of power outages on stability chambers. Unichem Laboratories promptly addressed and corrected these items during the inspection, leading to no formal required actions. This positive outcome indicates the company's adherence to regulatory expectations for pharmaceutical manufacturing.