FDA 483 - Cipla Limited - April 17, 2026

Cipla Limited, a drug manufacturer in Salcette, Goa, India, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic processing validation, including inadequate airflow studies and control over personnel gowning excursions. Additionally, the firm's Quality Unit demonstrated insufficient oversight of maintenance activities, failing to properly document and approve the release of areas back to aseptic operations after repairs.