Inspections, Compliance, Enforcement, and Criminal Investigations
Teh Lin Prosthetic & Orthopedic, Inc. 12/23/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
DEC 23, 2011
VIA UNITED PARCEL SERVICE
Mr. Sen Hua Chen
President and Chairman of the Board
Teh Lin Prosthetic & Orthopedic, Inc.
No.7, Wu Chuan 7th Road
Wu Ku Industrial Park
Taipei 242, Taiwan
Dear Mr. Sen Hua Chen:
During an inspection of your firm located in Tapei, Taiwan on August 22, 2011, through August 25, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures external limb prosthetic components orthopedics. 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 are intended to affect the structure or function of the body.
Our inspection revealed that the 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 21 CFR Part 803- Medical Device Reporting. These violations include, but are not limited to, the following:
Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
Given the serious nature of the violations of the Act, the external limb prosthetic orthopedic devices manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be misbranded. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm's response appears to be adequate, and we may need to re-inspect your firm's facility to verify that the appropriate corrections and/or corrective actions have been made.
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 awarding of contracts.
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. Please provide a translation of documentation not in English to facilitate our review.
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act (21 U.S. C. § 351(h)), which are deficiencies within your firm's quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformities include, but are not limited to, the following:
Failure to adequately maintain complaint files, and establish and maintain adequate procedures for receiving, reviewing , and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
1. Complaints are not evaluated to determine whether the complaint represents an event that is required to be reported to the FDA under part 803 (Adverse Event/Medical Device Reporting)
2. Complaint files did not include the returned or repaired devices under warranty.
Your firm's response to this letter should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to the Unique Identification Number (CMS case #255614) when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585 or by fax at 301-84 7-8139.
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 lnspectional 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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health