FDA 483 - Bora Pharmaceutical Services Inc. - January 28, 2025

Bora Pharmaceutical Services Inc., a contract manufacturer of human drug products in Mississauga, was cited for nine observations during an FDA inspection. The inspection revealed significant deficiencies across quality control, laboratory operations, stability testing, and batch record management. Key issues include inadequate analytical testing for product release, insufficient review of production records, non-compliance with stability protocols, incomplete instrument qualifications, and poor control over labeling materials.