FDA WARNING_LETTER - Whitehall/Div of Acorn Engineering Co - March 23, 2017

On July 12, 2017, the FDA issued a Warning Letter to Whitehall/Division of Acorn Engineering Company following an inspection from March 6-23, 2017. The inspection revealed that the firm's whirlpool immersion hydrotherapy and dry heat therapy devices are adulterated under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System Regulation (21 CFR Part 820).

Key violations include: 1. **Complaint Handling (21 CFR 820.198):** Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints, including determining reportability to FDA (21 CFR Part 803) and maintaining complete investigation records. The firm's updated procedures were deemed inadequate. 2. **Complaint Investigations (21 CFR 820.198(c)):** Failure to investigate device failures or maintain documentation of investigations for numerous complaints, including units not heating, motors burning out/seizing, defective turbines, and GFCI trips. The firm's response was inadequate, lacking a retrospective review plan or future corrective actions. 3. **Design History File (21 CFR 820.30(j)):** Failure to establish design history files for Thermo Therapy dry heat devices, Little Champ Hydro Whirlpool devices,