FDA WARNING_LETTER - Battle Creek Equipment Co. - February 12, 2015

On April 3, 2015, the FDA issued a Warning Letter to Battle Creek Equipment Co. following an inspection from January 27 to February 12, 2015. The inspection revealed that the firm's Thermo MaxHeat, Custom Touch, and Thermophore Classic heating pads are adulterated devices under 21 U.S.C. § 351(h) because their manufacturing, packing, storage, or installation methods and controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

The letter detailed multiple violations, including: 1. **Failure to establish and maintain design change procedures (21 CFR 820.30(i))**: The firm lacked a written procedure for design changes, and failed to validate or verify changes like the switch modification for Thermo MaxHeat and the cord change for Thermophore Classic. 2. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a))**: The CAPA procedure did not define actions for nonconforming products, including those in the market, and corrective actions were implemented without following established procedures (e.g., PIPE/SCAR forms). 3. **Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a))**: Procedures did not require evaluation of complaints to determine investigation necessity