FDA 483 - Technicuff Corp. - April 24, 2024

During an inspection conducted from April 22-24, 2024, the FDA issued a Form 483 to Technicuff Corp., a medical device manufacturer located in Leesburg, FL. The inspection revealed several deficiencies in the company's quality system, indicating non-compliance with regulatory requirements. Key issues identified include the absence of established procedures for controlling nonconforming products, leading to finished goods being stored in an inadequately marked quarantine area. Technicuff also lacked valid statistical techniques for establishing and verifying product and process acceptability, specifically regarding sample sizes for incoming material verification, which was noted as a repeat violation. Furthermore, the company failed to appoint a designated management representative responsible for the quality system. Document control procedures were found to be inadequate, with critical documents like the "Quality Policy" lacking approval dates and signatures, and the "Purchasing Control Policy" missing proper revision details. A repeat violation was also noted for insufficient procedures to ensure purchased products and services conform to specifications, particularly regarding contract manufacturer validation. Technicuff Corp. has acknowledged these observations and committed to implementing corrective actions.