- Taicang Sheng Jia Medical Equipment Science & Technology Co.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
MAR 10, 2015
VIA UNITED PARCEL SERVICE
Sheng Rong Bing
Taicang Sheng Jia Medical Equipment
Science & Technology Co., Ltd.
No. 18 Pai Jiu Road
Jinlang, Fuqiao, Taicang
Jiangsu, China 215423
Dear Mr. Bing:
During an inspection of your firm located at No. 18 Pai Jiu Road, Jinlang, Fuqiao, Taicang, Jiangsu, China, facility on November 10 through November 12, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wheeled stretchers. 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 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 (MDR). These violations include, but are not limited to, the following:
1. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm has no written MDR procedures.
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 (which must address systemic problems) 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:
2. Failure to document all activities required under 21 CFR 820.100, and their results, as required by 21 CFR 820.100(b). For example, your firm’s corrective and preventive actions (CAPA) procedure states that personnel should be trained to address nonconforming product issues. However, CAPA report # 13-06-18-01 involving a nonconformance did not indicate that the personnel were trained.
3. Failure to establish and maintain records of acceptable suppliers, contractors, and consultants, as required by 21 CFR 820.50(a)(3). For example, your firm’s approved supplier list did not include the foreign supplier of the hydraulic pumps.
4. Failure to promptly review, evaluate, and investigate complaints that represent an event which must be reported to the FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(d). For example, your firm’s complaint handling procedure does not include the requirement of evaluating complaints for reportability under 21 CFR 803.
5. Failure to document, for validated processes, the monitoring and control methods and data, the date performed, and where appropriate, the individuals performing the process or the major equipment used, as required by 820.75(b)(2). For example, your firm did not have documentation for the welding process validation.
6. Failure to document the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation, in the Design History File (DHF), as required by 21 CFR 820.30(g). For example, the DHF for the (b)(4) stretcher did not document the raw data and protocol used for the design validation.
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 # 447470) when replying.If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch at telephone +1 (301) 796-5587, or fax +1 (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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and