SHANGHAI RUIKE SPORTS GOODS CO., LTD. 11/23/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
November 23, 2012
VIA UNITED PARCEL SERVICE
Mr. Cheng Xin Fu
Shanghai Ruike Sports Goods Co., LTD.
689 Xinhu Road
Dear Mr. Cheng Xin Fu:
During an inspection of your firm located in Shanghai, China,on July 16, 2012, through July 19, 2012, an investigator from the United States Food and Drug Administration determined that your firm manufactures class II motorized three-wheeled vehicles. 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.
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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s service and customer feedback control procedure does not require that customer complaints be evaluated to determine whether the complaint represents an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting.
2. Failure to ensure that calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards, as required by 21 CFR 820.72(b)(1). For example, calibration records for measuring equipment did not show that the equipment was calibrated to standards traceable to national or international standards. Specifically the measuring equipment:
3. Failure to establish and maintain procedures for implementing corrective and preventive action, including requirements for implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, as required by 21 CFR 820.100(a)(5). For example, corrective and preventive actions do not show that the corrective or preventive measures identified were implemented. Specifically:
A. Improvement measure for mobility scooter, model 3331, dated April 18, 2012, was implemented due to the (b)(4). Documentation of the action indicates that the returned parts would be returned to the supplier. The supplier would be notified in writing to adhere to the specifications, and the incoming acceptance inspection for the (b)(4) would be enhanced. However, there was no documentation demonstrating that the incoming inspection was enhanced.
B. Improvement measure for mobility scooter, model 3431, dated June 20, 2008, was implemented due to the (b)(4). Documentation of the action indicates that the vendor would be asked to pay more attention to the quality of the product, the incoming inspection would be strengthened, and a notification would be sent to the supplier asking them to strictly follow the (b)(4). However, there was no documentation demonstrating that these improvement measures were implemented.
C. Improvement measure for mobility scooter, model 3331 and 3431, dated June 17, 2008, was implemented due to the (b)(4). Documentation of the action indicates that the customer would be asked to pay more attention to quality and to perform stricter testing on the next incoming batch. However, there was no documentation demonstrating that these improvement measures were implemented.
4. Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, the device master record for the scooter model 3331 lacks procedures for how to perform the testing defined in your firm’s procedure RK-QP-8.2.3-2012 for finished device inspection and testing.
5. Failure to establish and maintain adequate procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of this part, as required by 21 CFR 820.184. For example, the device history records for the RK-3331 Mobility Scooter do not include or refer to the location of the labeling applied to the devices.
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 21 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 803.17.
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. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations 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.
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 363619 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585.
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