Spinetronics, LLC – FDA Warning Letter, Mar 1, 2011

On February 28 - March 1, 2011, an FDA inspection of Spinetronics, LLC in Coral Springs, Florida, revealed that their Antalgic-Trak device was adulterated and misbranded. The device was adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and under 21 U.S.C. § 351(f)(1)(B) for lacking marketing clearance or approval.

Violations of QS regulation included: - Failure to establish and maintain design control procedures (21 CFR 820.30(a)(1)), lacking documentation for design validation, design change controls, risk analysis, or structural testing of embedded software. - Failure to establish and maintain procedures for finished device acceptance (21 CFR 820.80(d)). - Failure to establish and maintain purchasing control procedures (21 CFR 820.50), including lack of awareness of contract manufacturer's quality system activities. - Failure to establish and maintain nonconforming product procedures (21 CFR 820.90(a)). - Failure to establish and maintain Corrective and Preventive Action (CAPA) procedures (21 CFR 820.100(a)). - Failure