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

During an FDA inspection conducted from May 12-20, 2025, at Kemwell Biopharma Private Ltd, a contract manufacturer of human drugs in Bengaluru, India, several significant observations were noted on an FDA Form 483, indicating failures to adhere to current Good Manufacturing Practices (cGMP).

Observation 1 highlighted deficiencies in written procedures for in-process controls and examinations. Specifically, the firm lacked scientifically justified acceptance criteria for visual inspection of finished sterile drug products and failed to establish in-process defect limits. Additionally, a single, general Standard Operating Procedure (SOP) was used for audit trail reviews across various computerized GMP systems, lacking system-specific instructions for critical events, data interpretation, timeframes, and documentation, leading to inconsistent practices.

Observation 2 detailed issues in preventing microbiological contamination of sterile drug products. The aseptic personnel qualification process did not adequately specify activities required during media fills to demonstrate competency for critical tasks. Personnel monitoring of gloves was improperly conducted immediately after sanitization, potentially yielding false negatives. Fingertip monitoring was omitted during a smoke study, compromising its validity. Furthermore, operators performing aseptic connections in Grade A areas had forearms monitored to less stringent Grade B standards without scientific justification, increasing microbial contamination risk.

Kemwell Biopharma is required to formally respond to the FDA regarding these observations, outlining implemented or planned corrective actions to address the identified deficiencies and ensure compliance with regulatory standards for sterile drug manufacturing.