FDA 483 - Kilitch Healthcare India Limited - October 20, 2023

This FDA Form 483 was issued to Kilitch Healthcare India Limited, a sterile drug manufacturing facility located at R - 904 905 TT C Industrial Road, Navi Mumbai, Maharashtra, 400706 India (FEI Number: 3011853060). The inspection was conducted from October 12, 2023, to October 20, 2023, by Investigators Anastasia M Shields and Justin A Boyd. The report was issued to Paresh Mehta, Managing Director.

The primary observation noted was that procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed. Specific instances of improper aseptic processing technique were observed during setup, aseptic filling, and transfer disassembly/cleaning in the Grade A area of equipment and components, and line cap and bottle lines used for U.S. marketed drug products.

Key deficiencies included: 1. On October 12, 2023, and October 17, 2023, operators in the Grade A area performing line setup, aseptic filling, and equipment transfer and cleaning were not wearing goggles, resulting in skin exposure. 2. On October 12, 2023, operators in the Grade A area had exposed skin on their nose throughout the aseptic filling process of a specific batch and repeatedly performed interventions, including leaning over the filling line