FDA WARNING_LETTER - Handsome Industrial (H.K.) Co., LTD - March 27, 2014

On August 4, 2014, the FDA issued a Warning Letter to Handsome Industrial (H. K.) Co., Ltd (HIC) following an inspection from March 24-27, 2014, which found their electrical heating pads (devices) to be adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Complaint Handling (21 CFR 820.198(a)):** No established procedures or designated unit for complaint handling. The firm's response to develop an SOP by May 31, 2014, was inadequate as no procedure was provided, and no retrospective review of complaints was planned. 2. **Nonconforming Product Control (21 CFR 820.90(a)):** No procedure for controlling nonconforming products. The firm's response to write a procedure by June 31, 2014, was inadequate as no procedure was provided, and no risk analysis of the lack of control was presented. 3. **Product Identification (21 CFR 820.60):** Failure to establish procedures for identifying products at all stages. Unidentified materials and products were observed. The firm's response to