• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

TCM Supply Corporation 8/16/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax          (949) 608-4415 

 

WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
SIGNATURE REQUIRED
                                                                                                                                             W/L 37–12
August 16, 2012                                            
 
Mr. Rock Lee, President
TCM Supply Corporation
15410 Stafford St.
City of Industry, California 91744
 
Dear Mr. Lee:
 
During an inspection of your firm located in City of Industry, California, conducted from March 06, 2012 through April 25, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm operates as an (b)(4) initial distributor of TDP Electronic Health Lamps under trade names Sacred Crane TDP Lamp and The Special Electromagnetic Therapeutic Apparatus; the Synatron 2000 (Low Frequency Electronic Pulse Device), also referred to as the Synatron 2000 TENS unit; Natural Sterile Acupuncture Needles (Natural Brand Interdermal Needle and Bleeding Needles); Natural Sterile Ear Press Needles; 7 Star Needle (Acupuncture Needles); Acuzone Acupuncture Needles; and Sharp Sterile Acupuncture Needles.  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 received a response from you, dated April 26, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Your response is not adequate because it does not address any of the 483 observations cited. Noted violations include, but are not limited to, the following:  
 
  1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, procedures for corrective and preventive action have not been established.
  2. Failure to maintain complaint files and failure to establish and maintain 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.
  1. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm does not have a quality agreement between (b)(4)(supplier of Synatron 2000 components) and your firm. Also, there was no documentation that any evaluations or qualifications of suppliers of components used for the Synatron 2000 have been performed.
  2. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm does not have procedures for inspections, tests, or other verification activities to control receiving of components used for the Synatron 2000.
  3. Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, while your firm is responsible for repackaging the Synatron 2000 with various components for distribution, your firm does not have procedures established for finished device acceptance for the Synatron 2000.
  4. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation to prevent mix-ups, as required by 21 CFR 820.60. For example, your firm does not have procedures for identifying product for the Synatron 2000. It was observed that there were no lot numbers on the packaged complete units of the Synatron 2000 held at the TCM Supply Corporation warehouse. (b)(4) complete units of the Synatron 2000 have been sold and distributed within the last two years; none had lot numbers or control numbers assigned.
  1. Failure to maintain device history records (DHRs), as required by 21 CFR 820.184. For example, your firm does not have DHRs for the Synatron 2000. Additionally, there is no procedure to establish and maintain a DHR. 
  2. Failure to maintain device master records (DMRs) as required by 21 CFR 820.181. For example, your firm does not have a DMR for the Synatron 2000. 
  3. Failure to establish and maintain procedures to control all documents, as required by 21 CFR 820.40. The procedures shall provide for the following: document approval, distribution, and changes. For example, procedures to control all documents have not been established. Specifically, your firm has not established procedures to control all documents required by the Quality System regulation to include approval, removal of obsolete documents, and control of changes to documents, including review, approval date, and signature.
  4. Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency, as required by 21 CFR 820.20(c). For example, management review procedures have not been established. There was no evidence provided that management reviews were conducted and documented.
  5. Failure to establish procedures for quality audits and to conduct such audits to assure that the quality system is in compliance with the established system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, when the FDA investigator asked if your firm has procedures for quality audits, you responded that the firm did not have procedures for quality audits.
 
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.  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 Sacred Crane TDP Lamp and The Special Electromagnetic Therapeutic Apparatus are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 Sacred Crane TDP Lamp and The Special Electromagnetic Therapeutic Apparatus, are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution in that a notice or other information respecting the new intended use of the devices was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 C.F.R. 807.81(a)(3)(ii). 
 
Specifically, the Sacred Crane TDP Lamp was cleared under K991503 with indications for use to emit energy in the infrared spectrum to provide topical heating for the purpose of temporarily elevating local tissue temperature and to use for the temporary relief of minor muscular and joint pain, to relax muscles, and to temporarily increase local blood circulation where applied. The Special Electromagnetic Therapeutic Apparatus was cleared under K963728 with indications for use to temporarily relieve minor muscular and joint pain and to temporarily increase local blood circulation where applied. However, your firm is marketing the Sacred Crane TDP Lamp and the Special Electromagnetic Therapeutic Apparatus for physical therapy functions such as soft tissue injury, sciatica, lumbago, rheumatoid arthritis, and omitis. The user manual states, “when getting energy under the heat of electro power, elements contained by the plate can be triggered to produce a comprehensive electromagnetic wave with different wavelength (2-21 µm) and different energy (range 28-35 mW/cm2) which is compatible with the BIO-Spectrum waves released by the body.” The user manual also claims that, “absorbed electromagnetic wave can promote some unstable structures (such as perish cells, pathological change dimmers, etc) to disorganization, increase body organs coordination, and immunity, speed patients to recover and heighten people’s resistibility to various diseases.”
 
The Sacred Crane TDP Lamp and the Special Electromagnetic Therapeutic Apparatus are cleared for providing temporary relief of minor muscle and joint stiffness and to increase local circulation. Statements that the devices can be used for treatment or prevention of a specific condition or disease state represent a new intended use and require a new 510(k).
 
Our inspection also revealed that the Synatron 2000, also referred to as the Synatron 2000 TENS unit, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 Synatron 2000 is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).                                                                                        
 
Our inspection also revealed that the Natural Brand sterile Bleeding Needles, Natural Brand sterile Ear Press Needles, 7-Star acupuncture needles, and Acuzone Needles are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g).  These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). 
 
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 only single use, acupuncture needles for fiscal year 2012.
 
Therefore, all of your firm’s devices, other than the single use, acupuncture needles, are also 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)).
 
A follow up inspection will be required to assure that corrections and/or corrective actions are adequate. 
 
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.
 
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
19701 Fairchild
Irvine, CA   92612
 
If you have any questions about the content of this letter, please contact Ms. Diane C. Van Leeuwen, Acting Compliance Officer, at 949-608-2978.
 
Sincerely yours,
/S/
Alonza E. Cruse, Director
Los Angeles District
 
 
Cc:       Ingeborg Small
            Branch Chief
            Food and Drug Branch
            California Department of Public Health
            1500 Capitol Avenue - MS 7602
            P.O. Box 997413
            Sacramento, California 95899-7435