FDA 483 - Prodose, Inc. - November 01, 2023

An FDA inspection of Spirit Pharmaceuticals, a packager of OTC drug products in Ronkonkoma, NY, revealed significant deficiencies. Observations included inadequate computer system controls with shared passwords, failure to qualify bulk drug product suppliers, and lack of a written stability testing program to support extended expiry dates. These issues indicate a lack of robust quality control and data integrity practices.