- Mayfair Medical Supplies Ltd
- 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
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