FDA WARNING_LETTER - Kwonnie Electrical Products Limited - September 06, 2007

An FDA inspection of Kwonnie Electrical Products Limited in Dongguan, China, from September 3-6, 2007, revealed that the firm's manufactured paraffin baths, classified as medical devices, are adulterated and misbranded. The devices are adulterated under 21 U.S.C. § 351(h) because manufacturing methods and controls do not conform to the Quality System (QS) regulation (21 C.F.R. Part 820). Key QS violations include failures in process validation, revalidation after changes, equipment design and maintenance, maintaining device master records, acceptance activities, storage area control, design transfer, design validation, control of nonconforming product, and purchasing controls. The devices are also misbranded under 21 U.S.C. § 352(t)(2) due to non-compliance with Medical Device Reporting (MDR) regulations (21 C.F.R. Part 803), specifically failing to establish and maintain written MDR procedures and adequate documentation/recordkeeping. The firm's October 23, 2007, response regarding MDR procedures was found inadequate. Consequently, all paraffin bath models are subject to refusal of admission into the U.S. (detention without physical examination). Federal agencies will be informed, potentially affecting contracts, and premarket approvals or Certificates to Foreign Governments will be withheld. Kwonnie must provide a written response within fifteen working days detailing specific corrective actions, prevention plans, supporting documentation, and a timetable for completion, including English translations for non-English documents.