Inspections, Compliance, Enforcement, and Criminal Investigations

Mayfair Medical Supplies Ltd 9/23/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993 

 

WARNING LETTER
September 23, 2014
 
VIA UNITED PARCEL SERVICE
 
Chun Fai Wong
Chairman and Director
Mayfair Medical Supplies Ltd
16/F., Rm 1605-1611, 238 Nathan Road
Kowloon, Hong Kong SAR
People’s Republic of China
 
 Dear Mr. Chun Fai Wong:
 
During an inspection of your firm located in Kowloon, Hong Kong, SAR,on May 12, 2014, through May 15, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures therapeutic infrared heating lamps, neuromuscular stimulators, and single-use acupuncture needles.  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.
 
We received your response dated May 28, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. In addition, we received your response dated July 23, 2014; however, it did not appear to contain any additional information related to the violations cited below. We address your response dated May 28, 2014, below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Failure to establish and maintain procedures for handling and reviewing complaints, as required by 21 CFR 820.198. For example:
 
a.    Your firm's complaint handling procedures do not include requirements to ensure that:
 
i.    Complaints are processed in a uniform and timely manner;
ii.    Complaints are documented upon receipt, including oral and email complaints; and
iii.    Complaints are evaluated for MDR reportability.
 
b.    Your firm's complaint handling procedures do not include requirements to ensure that a maintained complaint record includes:
 
i.    The reason that no investigation was performed, if no investigation is performed; and
ii.    The name of the individual responsible for the decision not to investigate, when no investigation is performed.
 
c.    Your firm’s complaint handling procedures do not include requirements which ensure that the records of investigation include:
 
i.    The name of the device;
ii.    The date the complaint was received;
iii.    Any device identification and control number;
iv.    The name, address, and phone number of the complainant;
v.    The nature and details of the complaint;
vi.    The dates and results or the investigation;
vii.    Any corrective action taken; and
viii.    Any reply to the complainant.
 
d.    The following information was not recorded for the three complaints received by your firm: 
 
i.    A complaint form was not completed for complaint Date March 31, 2012, (b)(4) and (b)(4). The following information was not recorded: the model name of the device; the device identification and control number; the date the complaint was received; the address, and phone number of the complainant; the date of the investigation; and the replies to the complainant.
 
ii.    The following information was not recorded for complaint Date May 30, 2013, and (b)(4): the model name of the device; the device identification and control number; the address and phone number of the complainant and the date of the investigation; and the replies to the complainant.
 
iii.    The following information was not recorded for complaint Date January 6, 2014, and (b)(4): device identification control number; address and phone number of the complainant; and date of the investigation.
 
We reviewed your firm’s response to the violations above and conclude that it is not adequate. Your firm did not perform a retrospective review of previous complaints to determine if information was properly recorded or missing, or if additional corrective action was required as a result.
 
2.    Failure to establish and maintain procedures for acceptance activities, which include inspections, tests, or other verification activities, as required by 21 CFR 820.80(a). For example, your firm’s acceptance procedures do not outline acceptance criteria and specify requirements for acceptance activities.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not perform retrospective reviews to determine if inspections, verifications, and final acceptance activities were performed to ensure your firm’s devices met final acceptance criteria in your firm’s device master record (DMR).
 
3.    Failure to establish and maintain procedures for implementing corrective and
preventive action, as required by 21 CFR 820.100(a). For example:
 
a.    Your firm’s corrective and preventive action procedures do not include requirements for:
 
i.    Analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology, where necessary; and
 
ii.    Verifying and validating corrective and preventive actions to ensure that such actions do not adversely affect the devices. 
 
b.    There was no documentation of the investigation and the corrective and preventive actions for CAPAs (b)(4), (b)(4), and (b)(4). These CAPAs were closed without verifying or validating the actions to ensure that such actions were effective and did not adversely affect the finished device.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not perform retrospective reviews of closed CAPAs and contemporaneous quality data to determine if new CAPAs should be opened, and closed CAPAs were not verified or validated as effective.
 
4.    Failure to establish and maintain procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).
 
For example, your firm's design change procedures include requirements that ensure all design changes and modifications are identified, documented, reviewed and approved by authorized personnel (the manager/director) before implementation. However, Confirmation Contract Letters dated January 3, 2012, which were signed by your firm, the contract manufacturers, and associated import/export firms, require notification and documentation of design changes made by contract manufacturers within 30 days after implementation.
 
Additionally, during the inspection, our investigator observed and informed your firm’s management that your firm’s contract manufacturer had made changes to the Device Master Record (DMR) of your class 2, 510(k) K061080, IR lamp without your firm’s prior approval. 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not perform retrospective reviews of these design changes to determine if these changes adversely affect the safety or efficacy of the device; were validated or verified and approved before implementation; or require the submission of a new 510(k).
 
5.    Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90. For example:
 
a.    Your firm’s nonconforming product procedures do not describe the documentation, evaluation, segregation, and disposition of nonconforming product. Specifically:
 
i.    The procedure requires defective products to be segregated to a designated area; however, the area is not specified;
ii.    The procedure lacks requirements for the evaluation and documentation of nonconforming products; and
iii.    There are no written criteria describing when a Corrective Action Report is required.
 
b.    Your firm's nonconforming product procedures do not define the responsibility for review and the authority for disposition of nonconforming product.  Also, your procedures do not require documenting the justification for using nonconforming product and the signature of the individuals authorizing its use.
 
We reviewed your firm’s response to the violations above and conclude that it is not adequate. Your firm’s revised procedure did not define the location of the designated area for the disposition of nonconforming products and your firm did not perform a retrospective review to determine if nonconforming products were properly evaluated, documented, and segregated and whether corrective action reports were required.
 
6.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example:  
 
a.    Your firm failed to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. Your firm’s purchasing control procedure does not specify:
 
i.    The conditions to be met when deciding whether onsite supplier evaluation is necessary; and
 
ii.    The criteria when sample evaluations are required.
 
b.    Your firm failed to define the type and extent of control to be exercised over supplies, based on evaluation results. Specifically, the criteria for which supplier control activity should be performed are not specified for the monitoring of suppliers.
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm’s procedure does not specify criteria for which assessment methods must be used, and when, in order to approve new vendors. Your firm’s procedure requires notification only for design changes from contractors, but does not require notification for all changes in product or service so that your firm can determine whether the changes may affect the quality of a finished device. Your firm’s procedure for supplier audit lists the areas to be audited; however, the quality requirements for these areas were not specified.  Your firm’s procedure does not specify the requirements for follow-up inspections. Finally, there were no retrospective reviews performed to assess whether your firm’s current suppliers confirm to your requirements.
 
7.    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 DMR for the Infrared Lamp, 510(k) K061080, does not include or refer to the location of the following:
 
a.    Product process specifications;
b.    Quality assurance procedures and specifications; and,
c.    Labeling specifications for the U.S. products.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not perform retrospective reviews to determine if DMRs for its other devices shipped to the U.S. were maintained per your firm’s procedure, and if your firm was aware of any design and process changes contained in these DMRs that were initiated by your firm’s contract manufacturers.
 
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 (MDR).  Significant violations include, but are not limited to, the following:
 
8.    Failure to adequately develop, maintain and implement written MDR procedures as required by 21 CFR 803.17. For example, after reviewing your firm’s procedure titled, Procedure Manual (b)(4) Revision (b)(4), Effective Date: August 8, 2011, the following issues were noted:
 
a.    (b)(4) Revision (b)(4) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements.  For example, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 of the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
 
b.    (b)(4) Revision (b)(4) does not establish internal systems that provide for timely transmission of complete MDRs. Specifically, the following are not addressed:
 
i.    The procedure includes reference to the FDA 3500A form; however, there are no instructions for how to obtain and complete the FDA 3500A form; 
ii.    The circumstances under which your firm must submit supplemental or follow-up reports and the requirements for such reports; and
iii.    How your firm will submit all information reasonably known to it for each event.
 
c.    (b)(4) Revision (b)(4) does not describe how your firm will address documentation and record-keeping requirements, including:
 
i.    Documentation of adverse event related information maintained as MDR event files;
ii.    Information that was evaluated to determine if an event was reportable;
iii.    Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable and
iv.    Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
  
We reviewed your firm’s response dated May 28, 2014, and determined that it is not adequate. Your firm revised sections of its procedure, which is now titled Procedure Manual, (b)(4) Revision (b)(4), Effective Date: May 22, 2014. Sections 8.6.2,titled, Reporting of Medical Devices, 0.2, titled Revision Sheet, and 2, titled, Training Sessions were submitted for review. The training sessions were completed on May 24, 2014.
 
Although your firm made revisions to its procedure to update the MDR sections, the following deficiencies were still noted:
 
(b)(4) Revision (b)(4) does not establish an internal system that provides for timely transmission of complete MDRs.  Although the procedure includes reference to the FDA 3500A form there are no instructions for how to obtain and complete the FDA 3500A form.
 
a.       (b)(4) Revision (b)(4) does not describe how your firm will address documentation and record-keeping requirements, including:
 
i.    Documentation of adverse event related information maintained as MDR event files; and
ii.    Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014.  The requirements of this final rule will take effect on August 14, 2015.  If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
 
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
 
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 action (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. 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.
 
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 #433732 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 (telephone)or by (301) 847-8139 (fax).
 
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. 
 
 
Sincerely yours,
/S/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
   Radiological Health

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