FDA EIR - Neuland Laboratories Limited (Unit II) - February 07, 2020

A Post-Approval Inspection of Neuland Laboratories Limited Unit-II in Visakhapatnam, India, was conducted by the FDA from February 3-7, 2020. The inspection, guided by ICH-Q7 and the Food, Drug, and Cosmetic Act, focused on evaluating changes to the manufacturing process of an Active Pharmaceutical Ingredient (API), specifically (b) (4) drug substance, for the U.S. market. The inspection resulted in an FDA-483 listing two main observations and several verbally discussed issues. Key deficiencies included inadequate equipment cleaning, evidenced by leftover grease in a processing machine, and insufficient written procedures and physical mechanisms for hand cleaning and sanitization in critical material dispensing and sampling areas. The facility also had electronic data backup servers that were not appropriately protected against fire and physical shock. Additional concerns involved incomplete differential pressure logs, an unidentified water user point in the microbiology laboratory, and inadequate direct verification of temperature for incoming temperature-sensitive raw materials. An employee also demonstrated a lack of understanding regarding the water system during questioning. Neuland Laboratories Limited management acknowledged these deficiencies and committed to implementing corrective actions. They stated they would formally respond to the FDA within 15 working days to address all identified issues and ensure compliance with regulatory standards.