FDA 483 - Enzene Biosciences Limited - February 13, 2026

Enzene Biosciences Limited, a drug substance and drug product manufacturer in Pune, India, received a Form 483 for significant deficiencies observed during an FDA inspection. The findings highlight critical issues in aseptic processing, quality control procedures, adherence to written protocols, and overall quality oversight. These observations collectively indicate a high risk to product quality and sterility assurance.