FDA 483 - Kemwell Biopharma Private Ltd - May 20, 2025

During an inspection conducted from May 12-20, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Kemwell Biopharma Private Ltd, a contract manufacturer of human drugs located in Bengaluru, India. The inspection identified significant deviations from current Good Manufacturing Practices (CGMP) concerning process controls and aseptic manufacturing procedures.Key observations highlighted the absence of scientifically justified acceptance criteria and defect limits for visual inspection of sterile drug products, particularly for particulate matter and repeat inspections. Additionally, the company lacked system-specific written procedures for reviewing audit trails across various computerized GMP systems, leading to inconsistent practices and reliance on individual experience rather than documented guidelines.More critically, the FDA noted deficiencies in procedures designed to prevent microbiological contamination. These included an inadequate aseptic personnel qualification process that did not ensure operators demonstrated competency in critical tasks during media fills. Personnel monitoring practices were flawed, with glove monitoring occurring after sanitization, potentially yielding inaccurate results, and fingertip monitoring being omitted during smoke studies, compromising data validity. Furthermore, the company failed to apply appropriate Grade A microbial contamination standards to all personnel gowning entering Grade A areas, instead using less stringent Grade B standards for forearms, despite their presence in critical aseptic zones. Kemwell Biopharma Private Ltd is required to address these observations by developing and implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for drug manufacturing.