FDA 483 - Young Dental Manufacturing I, LLC - March 25, 2022

Young Dental Manufacturing I, LLC, a drug distributor in Earth City, MO, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to thoroughly investigate product complaints, lacking proper details, root causes, and corrective actions. Additionally, the company did not establish or follow adequate procedures to prevent objectionable microorganisms, specifically Burkholderia cepacia, in its non-sterile oral drug products and raw materials.