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

On October 12-20, 2023, the FDA inspected Kilitch Healthcare India Limited, a sterile drug manufacturing facility in Navi Mumbai, Maharashtra, India. The inspection, documented in a Form 483 issued to Managing Director Paresh Mehta, revealed significant deficiencies in aseptic processing, laboratory controls, and validation of sterile drug products.

Observation 1 highlights inadequate cleaning and disinfection in aseptic areas. The firm lacks assurance of effective sporicidal use, with no validation data for the [(b)(4)] process's efficacy against spores or its penetration. Disinfectant efficacy studies omitted critical surfaces like [(b)(4)], [(b)(4)], [(b)(4)], and [(b)(4)]. Additionally, mops used in the filling room were unsterilized and moved between Grade C and Grade B areas.

Observation 2 details unreliable laboratory controls. Environmental and personnel monitoring data are compromised due to issues with in-house prepared media, including insufficient media volume, desiccation, cracking, and lack of neutralizers, leading to disinfectant interference. The firm also lacks appropriate specifications for impurities or degradation products for US market [(b)(4)] products. During sterility testing, components were not fully submerged in media.

Observation 3 indicates inadequate validation of the aseptic process. Smoke studies for Lines [(b)(4)] and [(b)(4)] showed turbulent airflow and failed to include critical set-up activities or interventions. Aseptic Process Simulation (Media