• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

  • Print
  • Share
  • E-mail

Xiantao Rayxin Medical Products Co. Ltd. 10/5/12

  

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

OCT 5, 2012
 
VIA UNITED PARCEL SERVICE
 
Mr. Li Qichao
General Manager and Owner
Xiantao Rayxin Medical Products Co. Ltd.
No. 258 Pengchang Road Middle Street
Xiantao City, Hubei Province, China
 
Dear Mr. Qichao: 

During an inspection of your firm located in Xiantao City, China, on July 2, 2012, through July 4, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical masks. 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 a response from you dated July 16, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations that was issued to your firm.  We address this response 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 adequate procedures for implementing corrective and preventive action, including documentation, as required by 21 CFR 820.100(b).  For example, the corrective and preventive action procedure RX/QP-19 CAPA was not implemented.  Moreover,

a) The lack of design control procedures was identified in a management review meeting held December 8, 2011.  Although the corrective action was to establish a design control procedure and forms, this was not captured in the CAPA system.
b) The lack of a design history file (DHF) for the surgical face masks was identified in a management review meeting held December 8, 2011.  Although the corrective action was to establish a DHF for surgical face masks, this was not captured in the CAPA system.
c) The corrective action for CAPA #2010-2 requires additional steps to be included in the inspection of shipping containers.  However, there was no documentation that this method change was recorded in a procedure or on the inspection checklist.
d) The verification and validation activities for CAPA #MR-2011-12-01 did not ensure that corrective actions were effective.

The adequacy of your firm’s response cannot be determined at this time.  The response states that your firm anticipated completing corrective actions for points 1(a)-(c) above by August 10, 2012.  These actions included: updating your firm’s output list of management review for 2011; adding the establishment of a design control procedure and DHF to your firm’s CAPA list; updating RX/WH-03, Product Loading Procedure, and R/TE-302, rev.02, Shipment Inspection Report; and training administrative staff.  However, no evidence of the corrective actions has been provided.  Your firm’s response also stated that, by October 30, 2012, your firm anticipates completing its corrective action for part 1(d) above.  No evidence of this corrective action has been provided.

2. Failure to establish and maintain adequate procedures for verifying the device design to confirm that the design output meets the design input requirements.  The results of the design verification, including identification of the design, methods, the date, and the individuals performing the verification, shall be documented in the DHF, as required by 21 CFR 820.30(f).  For example, the design control procedure RX/TE-O5, Design Control Procedure, does not describe the methods for design verification.  In addition, the verification report for the face mask with ear loops, model 1530, does not demonstrate that outputs meet the input requirements.

The adequacy of your firm’s response cannot be determined at this time.  Your firm anticipates completing its corrective action by December 30, 2012.  However, we are unable to verify if this response is adequate because evidence of the completion of the corrective action has not been provided. 

3. Failure to establish and maintain adequate design validation procedures to ensure that devices conform to defined user needs and intended uses; to include risk analysis where appropriate; and to ensure the results of the design validation, including identification of the design, methods, the date, and the individuals performing the validation are documented in the DHF, as required by 21 CFR 820.30(g).  For example:

a) The design control procedure RX/TE-05, Design Control Procedure, does not include an approved study protocol that describes the operating conditions, use of production equivalent devices, and acceptance criteria for the face mask, model 1530.

b) Risk analysis of the design was not conducted.  For example, the Risk Management Report included in the DHF for face mask model 1530 identifies the device as "sterile face masks," and includes sterilization as a risk-reduction measure; however, these devices are not sterilized or marketed as sterile.  No additional documents addressing risk analysis of the face mask design were available for review.

The adequacy of your firm’s response cannot be determined at this time.  Your firm anticipates completing its corrective action by December 30, 2012.  However, we are unable to verify if the response is adequate because evidence of the completion of the corrective action has not been provided. 

4. Failure to establish and maintain adequate procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h).  For example, the design control procedure RX/TE-05, Design Control Procedure, does not adequately describe design transfer and there is no documentation that design transfer was conducted for face mask model 1530.

The adequacy of your firm’s response cannot be determined at this time.  Your firm anticipates completing its corrective action by December 30, 2012.  However, we are unable to verify if the response is adequate because evidence of the completion of the corrective action has not been provided.

5. Failure to establish and maintain an adequate DHF for each type of device to demonstrate that the design was developed in accordance with the approved design plan and design control requirements, as required by 21 CFR 820.30(j).  For example, the DHF was not established and does not demonstrate that the face mask designs were developed following the approved design plan.  Specifically:

a) A DHF was not established for face mask with tie, model 1540.

b) The DHF for face mask with ear loops, model 1530, does not  include all requirements described in the design plan.  For example,

1) Design validation is incomplete.
2) Design verification is incomplete.
3) Design transfer was not conducted.

The adequacy of your firm’s response cannot be determined at this time.  Your firm anticipates completing its corrective action by December 30, 2012. However, we are unable to verify if the response is adequate because evidence of the completion of the corrective action has not been provided.

6. Failure to establish 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, the purchasing procedure RX/QP-09, Purchasing Control, does not address the evaluation of contractors and consultants.  Specifically,

a) There is no documentation that the (b)(4) was evaluated and qualified to conduct equipment calibration.

b) There is no documentation that the quality consultant, (b)(4), was evaluated and qualified by the firm.

c) (b)(4) There is no documentation that (b)(4) was evaluated and qualified to perform this service.

The adequacy of your firm’s response cannot be determined at this time.  Your firm anticipated completing corrective actions by August 10, 2012. These actions included updating your firm’s RXQP-09 A1, Purchasing Control Procedure, and reviewing and evaluating service suppliers to determine if similar service suppliers “have not been distinguished to your qualification evaluation system.” However, we are unable to verify if your firm’s response is adequate because no evidence of the corrective action has been provided.  .

7. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).  For example, the complaint handling procedure, RX/QP-13, Customer Feedback Control, does not require documentation of the evaluation of Medical Device Reporting events.  None of the (b)(4) complaints received from 2010 to 2012 included documentation of an evaluation for MDR reportability.  

The adequacy of your firm’s response cannot be determined at this time.  Your firm anticipated completing its corrective action by August 10, 2012. These actions included updating RX/QP-13 A1, Customer Requirement and Complaint System Control Procedure, R/SA-05, Customer Feedback Record, and R/QA-18 A1, Corrective and Preventive Action Sheet. In addition your firm stated that it would “add evaluation of the necessity to file MDR report, and requirement of investigation and filing such a report.”  However, we are unable to verify if your firm’s response is adequate because no evidence of the corrective action has been provided.

A follow-up inspection may be required to assure that corrections and/or corrective actions are adequate.  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, Room 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993.  Refer to CMS case #348479 when replying.  If you have any questions about the contents of this letter, please contact: LaShanda Long at (301) 796-5465 or fax (301) 847-8137. 

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