# FDA WARNING_LETTER - K S Choi Corp - February 07, 2013

Source: https://www.keypedia.com/records/warning_letter/k-s-choi-corp/d01677d8-3f48-49d1-bc48-a98eb793f156

> FDA WARNING_LETTER for K S Choi Corp on February 07, 2013. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: K S Choi Corp
- Inspection Date: 2013-02-07
- Product Type: Devices
- Office Name: Los Angeles District Office
- Summary: 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)

## Related Officers

- [Director](https://www.keypedia.com/people/alonza-e-cruse/650e3631-3f99-45f7-863e-3a35c44be485)

Company: https://www.keypedia.com/companies/k-s-choi-corp/c165501f-8827-4293-b36c-5df6b531c4e8

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b