FDA 483 - Deepwater Chemicals, Inc - February 14, 2025

Deepwater Chemicals, Inc. in Woodward, Oklahoma, an API manufacturer, received a Form 483 with five observations during an inspection from February 11-14, 2025. The inspection revealed significant deficiencies in the firm's quality control unit responsibilities, batch record management, stability testing program, laboratory controls, and cleaning verification procedures. These issues indicate a lack of adequate controls to ensure the quality and purity of active pharmaceutical ingredients.