Yang Ming Industry (Zhejiang) Limited 8/15/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
August 15, 2012
VIA UNITED PARCEL SERVICE
Mr. Donald Wu
Chairman and CEO
Pihsiang Machinery Manufacturing Company Limited
No 108 Hsin-He Road, Hsin-Feng Hsiang
Hsinchu County, Taiwan
Dear Mr. Wu:
During an inspection of your subsidiary firm, Yang Ming Industry (YMI), located in Pinghu, China on May 21, 2012, through May 24, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Shoprider Streamer Sport Power Wheelchair. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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 function of the body.
Our inspection 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 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, failure to develop, maintain, and implement written Medical Device Reporting procedures as required by 21 CFR 803.17.
For example, your representative told our investigator that Medical Device Reporting is the responsibility of Pihsiang Machinery Manufacturing Company (PMMC), which is the parent company of YMI. Your representative also stated that YMI is responsible for reporting these events to PMMC and that YMI does not have a written procedure for Medical Device Reporting. The draft outline provided during the inspection is insufficient to demonstrate your compliance with the applicable regulation.
U.S. 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.
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, including 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 action (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. Please provide a translation of documentation not in English to facilitate our review.
Your firm’s response 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 CMS case #325498 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585 or 301-847-8139.
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 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.
Steven D. Silverman
Office of Compliance
Center for Devices and Radiological Health