FDA 483 - CD Acquisitions, LLC - August 22, 2023

CD Acquisitions, LLC DBA Certa Dose, a specification developer in Denver, CO, was cited with four observations during an FDA inspection. The firm's quality system was found to have significant deficiencies, particularly concerning corrective and preventive actions, supplier evaluation, management review, and internal quality audits. These issues indicate a lack of adequately established and followed procedures across several critical quality system elements.