K S Choi Corp 5/17/13
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
VIA UNITED PARCEL SERVICE
May 17, 2013
WL# 40 - 13
Mr. Kak Soo Choi, CEO
K S Choi Corp
179 W 39th St
Los Angeles, California 90037-1015
Dear Mr. Choi:
During an inspection of your firm located in Los Angeles, California, conducted from December 11, 2012 through February 07, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm operates as an importer/initial distributor of Acuzone Sterile Acupuncture Needles; Acuzone Intradermal Needles; 7 Star Needle (Acupuncture Needles); KSC DB Disposable Acupuncture Needles; and H.L. Seo Won Acupuncture Needles. Your firm also imports and distributes infrared heat lamps. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
We did not receive a response from you concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Noted violations include, but are not limited to, the following:
1. Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designed unit, as required by 21 CFR 820.198(a). Your firm has not defined, documented, or implemented a procedure that addresses uniform and timely processing of complaints, documentation of oral complaints, and evaluation of complaints for events to be reported to FDA as Medical Device Reports.
2. Failure to establish procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, your firm does not have a quarantine area for damaged or returned product.
3. Failure to establish procedures for performing and verifying servicing activities, as required by 21 CFR 820.200(d). For example, your firm services infrared heat lamps but has not documented such service.
4. Failure to establish procedures for maintaining records, as required by 21 CFR 820.180. For example, your firm does not maintain sterilization validation records for acupuncture needles you distribute which have sterilization specifications that differ from those found in the contract manufacturer’s medical device clearance.
Our inspection also revealed that your firm’s devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C.§ 360i, and 1 CFR Part 803 – Medical Device Reporting.
Significant violations include, but are not limited to, the following: failure to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. For example, your firm does not have a standard review process procedure that addresses the identification, communication, and evaluation of events subject to medical device reporting.
Our inspection also revealed that the AcuZone Acupuncture Needles, AcuZone Acupuncture Intradermal Needles, Natural Brand 3 Edged Needles, 7 Star Acupuncture Needles, and KSC DB Plus Disposable Acupuncture Needles are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g).
The AcuZone Acupuncture Needles, AcuZone Acupuncture Intradermal Needles, Natural Brand 3 Edged Needles, 7 Star Acupuncture Needles, and KSC DB Plus Disposable Acupuncture Needles are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because you did not notify the agency of your intent to introduce the device into commercial -distribution in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii). Specifically, the Acuzone Acupuncture Needles; 7 Star Acupuncture Needles; Acuzone Acupuncture Intradermal Needles; Natural Brand 3 Edged Needles are imported and distributed under your contract manufacturer’s 510(k) (b)(4).
In addition, you import and distribute 7-Star Acupuncture Needles under your contract manufacturer’s 510(k) (b)(4)
. However, the labeling and/or specifications attributed to the needles that you import and distribute do not adhere to the approved labeling and/or specifications for the cleared devices. For example, the Acuzone Acupuncture Needles and KSC DB Plus Disposable Acupuncture Needles differ in labeling, specifications and sterilization parameters/process change. The Acuzone Acupuncture Intradermal Needles differ in labeling, specifications and website claims. The Natural Brand 3 Edged Needles differ in physical characteristics and website claims. The 7-Star Acupuncture Needles differ in physical characteristics. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. § 360(k), is deemed satisfied when a PMA is pending before the agency. 21 C.F.R. 807.81(b). The kind of information you need to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information you submit and decide whether your product may be legally marketed.
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has fulfilled annual registration and listing requirements for: TDP Lamps (Models CQ-29, CQ-12, KS-9800, KS-9600-D) (ProCode: ILY); Elastic Bandage (ProCode:FQM); Hwangle Moxa Device, J Moxa Device, J Moxa Cones, Loose Moxa (ProCode:IMA); Electric Therapeutic Massager (ProCode:ISA); and T-Press Pellets, Cupping Set, Aluminum Press Pellets (ProCode:LYG) as actively marketed devices. However, your firm has not listed the following devices: Natural Brand Acupuncture Needles, Acupuncture Needles, TDP Lamp/(b)(4), and (b)(4).) These devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
We acknowledge receipt of your letter dated February 15, 2013, in response to the FDA483 issued to your firm. Your letter indicates that you have removed some medical claims and stopped distribution of some products on your website. We note, however, that you continue to make unsubstantiated medical and structure/function claims for the (b)(4) and your (b)(4) dietary supplements. You letter also addressed the Inspectional Observations by stating that you have a room for returned products; are using a service repair form; plan to develop MDR procedures; and assigned a team for complaint handling. However, you have not provided evidence of establishing and implementing procedures for returned/non-conforming products; product servicing; MDR; and complaint handling. Your response is deemed inadequate.
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation violations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected. A follow up inspection will be required to assure that corrections and/or corrective actions are adequate.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of the violations, and take prompt actions to correct the violations and bring the products into compliance.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (including any systemic corrective actions) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Dr. Raymond W. Brullo, Compliance Officer, at 949-608-2918 or email@example.com
Alonza E. Cruse, Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence