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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shanghai Shunlong Physical Therapy Equipment Co.

  

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

 

MAR 27, 2012
WARNING LETTER
 
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Chun Shan Xu
General Manager
Shanghai Shunlong Physical Therapy Equipment Co.
No. 359 Jiugan Road
Songjiang Dist.
Shanghai, China 201601
 
Dear Mr. Xu:
 
During an inspection of your firm located in Shanghai, China, on October 17, 2011, through October 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II patient care beds and Class I manual wheelchairs and walkers. 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 responses from you dated November 3, 2011, and December 29, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. We address these responses 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 receiving, reviewing, and evaluating complaints by a formally-designated unit, as required by 21 CFR 820.198(a).  For example, your firm’s procedures, (b)(4), do not adequately ensure that oral complaints are documented upon receipt and that complaints are evaluated for Medical Device Report (MDR) reportability. Specifically, none of the five complaints reviewed included documentation of your firm’s evaluation for MDR reportability and one of the complaints, which was received orally, did not document the date, time, and information received.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm provided updated procedures: (b)(4); however, your firm did not indicate or provide documentation that includes a description and evidence of implementation of any corrections and corrective actions (including consideration of systemic corrective actions) to ensure that complaints are received, reviewed, and evaluated in an effective manner. This includes providing documentation that your firm evaluated the five above-referenced complaints for MDR reportability, documented the required information for the oral complaint, and reviewed all other complaints for MDR reportability and required information.
 
2.    Failure to establish and maintain adequate procedures to ensure that formal, documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual who does not have direct responsibility for the design stage being reviewed, as required by 21 CFR 820.30(e). For example, your firm’s Design History File (DHF) records for the (b)(4) home care bed design project does not include formal design review requirements based on the Design Plan Form.  Additionally, the one formal review held for this project was a design output review that did not take into account design input requirements.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm provided an updated procedure, (b)(4); however, your firm did not indicate or provide documentation that includes a description and evidence of implementation of any corrections and corrective actions (including consideration of systemic corrective actions) to ensure that the design reviews outlined in the procedure are planned and conducted at appropriate stages. This includes providing documentation that design reviews were conducted for design project (b)(4) and other reviewed designs according to the revised procedures.
 
3.    Failure to establish and maintain adequate procedures for validating the device design to ensure that devices conform to defined user needs and intended uses, including  testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example:
 
  1. Acceptance criteria were not established prior to the performance of validation activities. Specifically, there were no documented acceptance criteria for the validation testing of the new design for the (b)(4) home care bed project;
  1. The results of design validation, including identification of the design, methods, the date, and the individuals performing validation, were not adequately documented in the DHF for the validation testing of the (b)(4) home care bed project; and
  1. For the one unit tested in the design validation testing, the report did not document whether the unit was an initial production unit or an equivalent unit.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm provided an updated procedure, (b)(4), however, your firm did not indicate or provide documentation that includes a description and evidence of implementation of any corrections and corrective actions (including consideration of systemic corrective actions) to ensure that devices conform to defined user needs and intended uses, including testing of production units under actual or simulated use conditions. This includes providing documentation that acceptance criteria for the new design for (b)(4) home care bed project were established, that all results of the completed design validation for the (b)(4) home care bed project were documented, and that your firm reviewed documentation of other design validation activities.
 
4.    Failure to establish and maintain adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). For example:
  1. Your firm’s procedure, Corrective and Preventive Action (CAPA) Control Procedure, does not include requirements for implementing and recording changes necessary to correct and prevent identified quality problems, nor does it require documentation of your firm’s verification that the corrective/preventive actions taken were effective and do not adversely affect the product; and
  1. One complaint reviewed involved an initiation of a CAPA investigation; however, no CAPA Form was available for the investigation as required by your firm’s procedure.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm provided updated procedures, (b)(4); however, your firm did not indicate or provide documentation that includes a description and evidence of implementation of any corrections and corrective actions (including consideration of systemic corrective actions) to ensure that corrective and preventive actions are effectively implemented and documented. This includes providing a CAPA Form documenting the investigation of the CAPA initiated for the complaint referenced above and reviews of other CAPAs that ensure corrective/preventive actions were verified or validated for their effectiveness and that they do not adversely affect the finished product.
 
5.    Failure to establish and maintain adequate procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, where appropriate, and failure to use sampling plans written and based on a valid statistical rationale, as required by 21 CFR 820.250(a) and (b). For example, the design validation testing of the (b)(4) home care bed design project had no statistical rationale for the testing of only one unit.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm provided an updated procedure, (b)(4), and stated that it will add a Verification Plan that will include a valid statistical rationale column. However, this Verification Plan was not provided, nor did your firm indicate or provide documentation that includes a description and evidence of implementation of any corrections and corrective actions (including consideration of systemic corrective actions) to ensure the use of valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics. The management of the Research and Development department and the General Manager stated that there was no valid statistical rationale for testing only one unit.
 
6.    Failure to establish and maintain adequate procedures to control labeling activities, as required by 21 CFR 820.120. For example:
 
  1. There was no documentation of the complete records of examination and release of device labeling, including date and signature of the examiner, included in the 11 device history records (DHRs) reviewed by the investigator. When asked to review the DHRs for the 11 units, the firm’s representative, (b)(4), indicated that your firm does not retain records for each bed, but retained records for each purchase order and provided the purchase order records. (b)(4) indicated that your firm does not document the review and approval of the labels.
  1. There was no documentation of the labels or labeling used for each finished product/lot reviewed in the 11 DHRs. When asked by the investigator if the firm retained copies of the labeling in the DHR records, the firm’s representative indicated that the firm does not retain copies of this labeling in the DHR.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm provided updated procedures: (b)(4); however, your firm did not indicate or provide documentation that includes a description and evidence of implementation of any corrections and corrective actions (including consideration of systemic corrective actions) to ensure the control of labeling activities. This includes documentation that examination and release of device labeling was completed and reviewed. It also includes documentation that your firm referred to the location of labels or labeling in the 11 DHRs referenced above and reviews of other DHRs for labeling activities.
 
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, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case 288084 when replying. If you have any questions about the contents of this letter, please contact: Matthew Krueger at 301-796-5585.
 
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