K S Choi Corp – FDA Warning Letter, Feb 7, 2013

On May 17, 2013, the FDA issued a Warning Letter to K S Choi Corp following an inspection from December 11, 2012, to February 07, 2013. The firm, an importer/initial distributor of acupuncture needles and infrared heat lamps, was found to have adulterated and misbranded devices.

Key violations included: 1. **Adulteration (21 CFR Part 820 - Quality System Regulation):** * Failure to establish procedures for complaint handling (21 CFR 820.198(a)). * Failure to establish procedures for controlling non-conforming product, lacking a quarantine area (21 CFR 820.90(a)). * Failure to establish procedures for servicing activities, with undocumented service of infrared heat lamps (21 CFR 820.200(d)). * Failure to establish procedures for maintaining records, specifically lacking sterilization validation records for acupuncture needles (21 CFR 820.180). * Marketing devices (AcuZone Acupuncture Needles, AcuZone Acupuncture Intradermal Needles, Natural Brand 3 Edged Needles, 7 Star Acupuncture Needles, KSC DB Plus Disposable Acupuncture Needles) without an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE)