FDA 483 - Unexo Life Sciences Private Limited - May 14, 2024

During an FDA inspection from May 1 to May 14, 2024, Unexo Life Sciences, Private Limited, an Over-The-Counter (OTC) drug manufacturer in New Delhi, India, was cited for significant violations of Good Manufacturing Practices (GMP). The observations highlight critical failures across quality systems, laboratory controls, facilities, equipment, production, and packaging. Key issues included a severely compromised quality system, where the Quality Control Unit failed to ensure data accuracy and integrity. Investigators found missing, incomplete, or intentionally fabricated batch records, and inadequate control over computerized systems. The company's Managing Director reportedly admitted to not having complete batch records and creating some on request.

Investigations into product discrepancies and adverse events were inadequate, lacking root cause analysis or corrective actions. Laboratory operations failed to validate test methods for US-marketed products, and crucial raw data and Certificates of Analysis were missing or deliberately erased from computers. Facility and equipment issues included unclean product-contact surfaces, faulty gauges, unreviewed alarms, and the use of unqualified equipment for US product manufacturing. Furthermore, essential controls for packaging and labeling were absent or not followed, leading to uncontrolled access to labeling materials and finished products lacking proper identification and manufacturing history. Unexo Life Sciences is expected to promptly address these observations through comprehensive corrective and preventive actions to ensure the safety, quality, and efficacy of its drug products.