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

This FDA Establishment Inspection Report details findings for Young Dental Manufacturing I, LLC, during an inspection conducted from March 23 to March 25, 2022, in Earth City, Missouri. The inspection focused on drug distribution activities and medical device manufacturing, primarily covering Quality and Facilities and Equipment Systems. This current inspection followed a previous one in 2016, which resulted in a Voluntary Action Indicated (VAI) classification for deficiencies including inadequate drug product storage conditions and complaint review processes.

The recent inspection identified two significant observations documented on an FDA Form 483. First, the firm failed to thoroughly investigate unexplained discrepancies or failures of drug product batches. Specifically, complaint investigations for foam drug products consistently failing to dispense lacked detailed analysis, root causes, and corrective and preventive actions (CAPAs). The company did not routinely review manufacturing or testing records for complaints nor report them to the contract manufacturer. Second, the firm lacked established, written, or followed procedures to prevent objectionable microorganisms in non-sterile drug products. This included a failure to test raw materials and finished non-sterile oral drug products for Burkholderia cepacia, despite regulatory requirements under 21 CFR 210/211 (Good Manufacturing Practices). Management was warned of their responsibility to adhere to the Food, Drug, and Cosmetic Act, implying the need to address these deficiencies to ensure product quality and safety.