Nemschoff Chairs, Inc. – FDA Warning Letter, Jul 25, 2014

During an FDA inspection from June 30 to July 25, 2014, Nemschoff Chairs, a manufacturer of patient treatment chairs, was found in violation of federal regulations. The firm's Serenity treatment chairs are deemed misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), for failing to report corrections or removals as required by 21 CFR Part 806.

Specifically, the firm failed to report six field corrections performed between November 29, 2011, and June 3, 2014, on the Serenity treatment chairs' integrated heating elements. These corrections, involving "heat service kits," addressed malfunctions like overheating causing burns to the chair or patient, reported by multiple complainants since 2011.

While Nemschoff Chairs committed to a retrospective review of engineering change and service notices, their August 15, 2014, response was inadequate as it did not explain how future failures to notify the FDA of field corrections would be prevented, nor did it provide an updated procedure for Recalls, Corrections, and Removals (SOP 10-40-05).

The FDA requires prompt corrective action within 15 business days, including documentation of systemic corrective actions and a timetable if corrections extend beyond this period. Failure