Department of Health and Human Services
Public Health Service
2098 Gaither Rd
August 13, 1997
Li Jun Feng, Director & Senior Engineer
Chongqing Bashan Instrument Factory
83 Shi Xin Rd
Chongqing, Sichuang Province, PRC 630039
Dear Mr Feng:
During an inspection of your firm located in Chongqing, PRC on March 4-27, 1997, our investigator determined that your firm manufactures the Teding Dianci bo Pu (TDP) Special Electromagnetic Therapeutic Apparatus. This is a device as defined by Section 201(h) of the Federal, Food, Drug, and Cosmetic Act (the Act). Our records indicate that a determination of substantial equivalence for your TDP Special Electromagnetic Therapeutic Apparatus was made in December 1996. This device was cleared with the folIowing indication, "For temporary relief of minor muscular pains and joint pains." However, labeling obtained by our investigator contained additional indications, such as, therapeutic effects for infertility, children's pneumonia, and diabetes.
Addition of these new indications requires the submission of a 510(k) and a determination of substantial equivalence. Therefore, this device is misbranded within the meaning of Section 502(o) of the Act because a notice or other information respecting it was not provided as required by section 510(k) and adulterated within the meaning of Section 501(f)(1)(B) of the Act because it is a class III device under section 513(f) which is required to have in effect an approved application for premarket approval (PMA) or an approved Investigational Device Exemption (IDE) and no such PMA or IDE is in effect. In addition, the above-stated inspection revealed that this device is adulterated within the meaning of Section 501(h) of the Act, in that the methods used in, or the facilities or controls used for manufacturing, packaging, storage, or installation are not in conformance with the 1978 Good Manufacturing Practices (GMP) for Medical Devices Regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820, as follows:
Failure to have adequate written procedures for performing planned and periodic audits of the quality assurance program, and failure to perform planned and periodic audits by appropriately trained individuals not having direct responsibility for the matters being audited, as required by 21 CFR 820.20(b). For example, your firm has failed to establish a planned and periodic audit program. This observation would also be a deviation from 21 CFR 820.22 of the QS regulation.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. The specific violation noted in this letter and in the form FDA-483 issued at the conclusion of the inspection may be symptomatic of serious underlying problems in your firm's manufacturing and quality assurance systems. You are responsible for investigating and determining the causes of the violation identified by the Food and Drug Administration. If the causes are determined to be systems problems, you must promptly initiate permanent corrective actions.
Federal agencies are advised of the issuance of all Warning Letters concerning devices so that they may take this information into account when considering the award of contracts. In addition, your device maybe detained upon entry into the United States until the premarket clearance issue is corrected.
Please notify this office in writing within 15 days of receipt of this letter, of the specific steps you have taken to correct the noted 510(k) violation. Please include any and all documentation to show that adequate correction has been achieved. In the case of fixture corrections, an estimated date of completion, and documentation showing plans for correction, should be included with your response to this letter. If documentation is not in English, please provide an English translation to facilitate our review. Please address your response and any questions to the Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Division of Enforcement II, General Hospital Devices Branch, HFZ-333, 2098 Gaither Rd, Rockville, MD 20850, to the attention of Ms Carolyn Niebauer.
Should you require any assistance in understanding the contents of this letter, do not hesitate to contact Ms Dorsey at the letterhead address or at 301-594-4618, extension 115.
Lillian J. Gill
Director, Office of Compliance
This page was posted on August 20, 2006.