Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm509401.htm
Timestamp: 2019-04-19 19:09:57+00:00

Document:
During an inspection of your firm located in Hangzhou, China on May 12, 2014, through May 15, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures forceps and endoscopes. 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 the Tiansong 4 mm Rigid Endoscope 0º 30º 70º Cystoscope is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C.§ 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).
a. A nonconformance was opened on January 8, 2013, to address burrs within the field of view of the endoscope. One of the corrective actions (b)(4). However, Procedure (b)(4) Endoscope Inspection, was not updated to reflect the change.
b. A nonconformance was opened on January 7, 2014, to address burrs within the field of view of the endoscope. Your firm failed to adequately investigate the cause of the nonconformance.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide a summary or evidence of a retrospective review of previous CAPA actions to ensure that causes of nonconformities and quality problems were adequately investigated and corrected.
2. Failure to establish and maintain procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your firm’s design control procedures do not contain requirements for establishing acceptance criteria for design validations. Additionally, your firm failed to document the evaluation of design validation data for endoscope A0322.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide a summary or evidence of a retrospective review of previous device design validation activities to ensure that your devices conform to defined user needs and intended uses.
3. Failure to document validation activities and results, where the results of a process cannot be fully verified by subsequent and test, as required 21 CFR 820.75(a). For example, your firm’s procedures do not require documentation of changes to process parameters prior to executing validation activities.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide a summary or evidence of a retrospective review of other process validations to ensure that your devices are manufactured using validated processes, where appropriate.
Given the serious nature of the violations of the Act, endoscope 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 adulterated. As a result, FDA is taking steps to refuse entry of these devices into the United States, 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 regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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.
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 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. 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 Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #435679 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at 301-796-5587 or by fax at 301-847-8138.

References: § 321
 § 351
 § 360
 § 360
 § 352
 § 381