Tonica Elektronik A/S – FDA Warning Letter, Aug 2, 2012

An FDA inspection of Tonica Elektronik A/S in Farum, Denmark, from July 30 to August 2, 2012, found their Magnetic Stimulators adulterated under 21 U.S.C. § 351(h) for non-compliance with the Quality System regulation (21 CFR Part 820). The firm's response to the FDA 483 was deemed inadequate. Violations include: 1) Failure to adequately validate processes where results cannot be fully verified, specifically for Cool B65 coils (21 CFR 820.75(a)). 2) Failure to establish procedures for design change identification, documentation, validation, review, and approval (21 CFR 820.30(i)). 3) Failure to establish procedures for verifying device design to confirm output meets input requirements, noted for Cool B70 coils (21 CFR 820.30(f)). Furthermore, the firm's catalog promotes four cleared coils for new, uncleared indications ("Motor Cortex," "Brain tissue") instead of the cleared "peripheral nerves." This makes the devices adulterated under 21 U.S.C. § 351(f)(1)(B) for lacking an approved PMA or IDE, and misbranded under 21 U.S.C. § 352(o) for failing to notify FDA of the new intended use (21 U.S.C. § 360(k), 21 CFR 807.81(a)(3)(ii)). Tonica Elektronik A/S must immediately cease unapproved claims and respond within fifteen business days with specific, systemic corrective actions and a timetable. Non-compliance could lead to seizure, injunction, civil money penalties, and denial of PMA applications or Certificates to Foreign Governments. A follow-up inspection is required.