FDA 483 - Quality Tech Services, LLC - June 17, 2025

Quality Tech Services, LLC, a contract manufacturer in Bloomington, MN, received a Form 483 citing two observations. The inspection revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures, including inadequate investigations and failure to identify recurring quality problems. Additionally, the firm's procedures for preventing contamination of medical devices in cleanrooms were found to be inadequately established and inconsistent.