| Public Health Service Food and Drug Administration |
10903 New Hampshire Avenue Silver Spring, MD 20993 |
Department of Health and Human Services
WARNING LETTER
VIA UPS EXPRESS AND FACSIMILE
FEB 18 2011
Michael Shieh
Owner and President
Tytan Medical, Corp.
No. 785, Cheng-Feng Rd.
Chuansha, Shanghai, Pudong, 1234, China
Dear Michael Shieh:
During an inspection of your firm located in Shanghai, China on October 25, 2010 through October 28, 2010 an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class I stethoscopes and Class II manual sphygmomanometers. 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.
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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements have been met, as required by 21 CFR 820.30(a).
For example: according to the General Manager and Production Manager there is no design control process established for the manual sphygmomanometers manufactured since 2004 because there were no design control procedures defined until May 2006. According to the General manager and production Manager these procedures have not been implemented for the manual sphygmomanometers to determine what elements of design control have previously been met, nor has a reevaluation of data been done as part of establishing design control. There is no documentation available for the following having been established for manual sphygmomanometers: a design plan, design plan, design inputs, design outputs, design review, design verification/validation, design transfer, and design history file.
2. Failure to adequately establish and maintain procedures for corrective and preventative action, as required by 21 CFR 820.100(a).
For example: corrective and preventative action procedure P-40008 Datum Management Procedures does not specifically define what manufacturing acceptance activity data will be analyzed; only “Analysis of Manufacturing” is defined. None of the data from the acceptance activities of the sphygmomanometer gage first (b)(4) point check and sphygmomanometer gage second (b)(4) point check are analyzed. According to the General Manager these are critical tests that are defined in the AAMI SP10 standard which the firm uses for sphygmomanometer production. Additionally, these (b)(4) point checks are the only acceptance activities performed to test the accuracy of the sphygmomanometer gage. According to the Production Manager, no corrective and preventative actions are being implemented for these activities.
3. Failure to adequately 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: complaint handling procedure P-70005 Customer’s Complaints Management Procedure fails to ensure that complaints are evaluated to determine whether the complaint represents an event which is required to be recorded to FDA under 21 CFR 803, Medical Device Reporting. The complaint form R-10005 Complaints Report does not contain a field for documenting an evaluation of complaints for MDR reportable events. Seven of (b)(4) complaints reviewed contained no documentation of an evaluation having been performed to determine if the complaint represents an MDR reportable event.
A follow up inspection will be required to assure that corrections are adequate. We will contact the appropriate people and request an establishment re-inspection. An FDA trip planner will be in touch with you to arrange a mutually convenient date for this inspection.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)) Also, U.S. federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to: Allen Wynn, Field Operations Branch/DRMO/OC 10903 New Hampshire Avenue Silver Spring, MD 20993. Refer to CMS Case # 155038 when replying. If you have any questions about the content of this letter please contact: Lorie Erikson by telephone at (301)796-7511.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Sincerely yours,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health
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