FDA 483 - Paragon Swiss - January 12, 2024

Paragon Swiss in Santa Clara, CA, was inspected from January 8-12, 2024, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of quality agreements and inadequate procedures for documentation and supplier qualification. Additionally, the firm's employee training program was found to be deficient, and there were issues with stability testing and release testing for active pharmaceutical ingredients and starting materials.