FDA WARNING_LETTER - Ad-Tech Medical Instrument Corporation - June 05, 2013

An FDA inspection of Ad-Tech Medical Instrument Corporation in Racine, Wisconsin, from April 17 to June 5, 2013, revealed that their Subdural and Depth Electrodes are adulterated under section 501(h) of the Act, as manufacturing methods and controls do not conform to the Quality System regulation (21 CFR Part 820). The firm received a Form FDA-483, and their responses dated June 24 and August 12, 2013, were reviewed. Key violations include the failure to adequately establish and maintain procedures for design changes (21 CFR 820.30(i)), specifically regarding major revisions to existing designs like combination electrodes and macro-micro contacts, and the failure to adequately establish and maintain procedures for implementing corrective and preventive action (CAPA) (21 CFR 820.100(a)), as evidenced by not generating a Corrective Action Request for a Class I recall. The FDA acknowledged the firm's commitment but requires verification of corrective actions during a future inspection. Additionally, the firm made significant modifications to cleared electrodes, such as subdural electrodes with macro-micro contacts, which may affect safety and efficacy and require new premarket submissions. Ad-Tech must take prompt action to correct these violations, notify the FDA within 15 business days with a detailed plan and documentation, and address systemic issues. Failure to comply may result in regulatory actions including seizure, injunction, civil money penalties, and impact on federal contracts and device approvals.