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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Usine Rotec Inc 1/7/13

  

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
 
January 7, 2013
 
VIA UNITED PARCEL SERVICE
 
Robert Jutras
President
Usine Rotec International, Inc.
125 Rue De L’Eglise
Baie Du Febvre, Quebec, Canada
J0G 1A0
 
Dear Mr. Jutras:
 
During an inspection of your firm located in Baie Du Febvre, Quebec, Canada on August 27, 2012, through August 30, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures patient beds. 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 September 14, 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 acknowledge receipt of your firm’s five additional responses dated September 26, 2012, October 3, 2012, October 11, 2012, October 25, 2012, and November 23, 2012. They were not reviewed because they were not received within fifteen business days of issuance of the FDA 483. These responses will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter.
 
We address the September 14, 2012 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 procedures for validating the device design, as required by 21 CFR 820.30(g). For example, your firm’s design validation procedures (Control of Design and Development P-7.3-1, multiple versions) did not include requirements to ensure that acceptance criteria were established prior to performance of validation activities. The procedure did not ensure that validation testing be conducted on production units. Additionally, during review of the design history file (DHF) for Design Project 2010-01 for the Versatech 1100 Bariatric Bed, the results of design validation, including identification of the design and methods, were not documented in the DHF.
  
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will revise its design control procedures to include design validation requirements and provide training. Your firm also indicated that a design revalidation of the Versatech 1100 Bariatric Bed will be conducted on production units and documented according to the revised procedures. However, your firm did not provide evidence of the completion of these activities. Additionally, your firm did not provide evidence that it considered a systemic corrective action to this deficiency, including a retrospective review of design validation activities for other devices.
  
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm’s procedures (Corrective and Preventive Action P-8.5-1, multiple versions), addressing the analyses of sources of quality data to identify existing and potential causes of nonconforming products or other quality problems, did not include all potential sources of nonconformities such as complaints and service records.  Additionally, the procedures did not include requirements for verification or validation of CAPAs, where necessary, prior to implementation.  Two reviewed CAPA files (DAC/CAPA: 12-001 and DAC/CAPA: 12-002) did not include documentation of all activities conducted and their results.
 
We reviewed your firm’s response and conclude that it is not adequate. The CAPA procedure was revised to include all potential sources of quality data to identify existing and potential causes of nonconforming products or other quality problems, including requirements for verification or validation of CAPAs, where necessary, prior to implementation. Your firm indicated that training will be provided. However, your firm did not indicate that a retrospective review of all previous CAPAs will be conducted and that your firm will complete and document all activities for the two CAPAs reviewed, DAC/CAPA: 12-001 and DAC/CAPA: 12-002. 
 
3. Failure to 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, your firm’s Complaint Handling Procedure P-8.5-2 Rev. 1 did not include requirements to ensure that all complaints are evaluated to determine whether the complaint should be filed as a Medical Device Report (MDR).  This procedure also lacked requirements to ensure that, where no investigation was made, the individual responsible for the decision not to investigate, and the reason why, are documented. Additionally, review of service records revealed incidents which met the definition of a complaint were not processed as complaints.
 
We reviewed your firm’s response and conclude that it is not adequate. The Complaint Handling Procedure was revised to include requirements ensuring that all complaints are evaluated to determine whether the complaint should be filed as a MDR and ensuring that complaints where no investigation was made included the reason why and the name of the individual responsible for the decision not to investigate. Your firm indicated that training will be provided. Your firm also indicated that a retrospective review of all service calls on device models sold to the US from the past (b)(4) will be conducted according to the revised procedure. However, your firm did not provide evidence that it completed a retrospective review of all complaints completed to ensure that they were evaluated to determine whether the complaint should be filed as a Medical Device Report and that they were completed as required. Your firm did not provide rationale for why only the service calls for the last (b)(4) were reviewed.    
 
4. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e). For example, your firm’s design control procedures (Control of Design and Development P-7.3-1, multiple versions) did not ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed, an individual who does not have direct responsibility for the design stage being reviewed, and any specialists needed.  These procedures also did not define appropriate stages of the device’s design where design reviews are required. Additionally, during review of Design Project 2010-01 for a bariatric bed, no documentation of design reviews held during the project was retained in the DHF.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will revise its design control procedures to include design review requirements and provide training. However, your firm did not indicate that it will retrospectively look at design reviews from all design projects and that it would complete and document design review for Design Project 2010-01 for a bariatric bed. 
 
5. Failure to establish and maintain procedures for verifying the device design, as required by 21 CFR 820.30(f). For example, your firm’s design verification procedures (Control of Design and Development P-7.3-1, multiple revisions) did not ensure that acceptance criteria were established prior to performance of verification activities. Additionally, design verification activities, including identification of the design, the date, and the individual performing the verification, were not documented in the DHF for Design Project 2010-01 for the Versatech 1100 Bariatric Bed.
 
We reviewed your firm’s response and conclude that it is not adequate.  Your firm indicated that it will revise its design control procedures to include design verification requirements and provide training. However, your firm did not indicate that it will retrospectively look at design verifications from all design projects and that it will complete and document design verification activities for Design Project 2010-01 for the Versatech 1100 Bariatric Bed.
 
6. Failure to document acceptance activities required by 21 CFR 820, as required by 21 CFR 820.80(e). For example, for twelve reviewed Device History Records (DHRs), not all required information for final acceptance inspection activities for (b)(4) testing was documented in the DHRs, including the signature of the tester, the date of testing, and the equipment used. Additionally, the in-process (b)(4) test inspection activities for the (b)(4) process were not documented.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided updates to its manufacturing procedure for beds and indicated that training will be provided. However, adequate DHRs for the (b)(4) devices reviewed and mentioned above were not provided, including documentation of final acceptance inspection activities for (b)(4) testing and documentation of in-process (b)(4) test inspection activities. In addition, your firm did not provide evidence that a retrospective review of all DHRs will be completed to ensure acceptance activities were documented as required.
 
7. Failure to establish procedures for quality audits and conducting such audits, as required by 21 CFR 820.22.  For example, according to your firm’s quality audit procedure (Internal Audit P-8.2-1 Rev. 0 dated (b)(4)), Section 4.1 requires audit plans to be prepared so that audits are conducted at intervals not exceeding (b)(4) and Section 4.4 requires printed audit reports to be completed within (b)(4) after audit results. No audit plan was completed and no documented audit reports were completed for (b)(4) and (b)(4), although your firm’s management stated that audits had been conducted. Your firm’s Quality Control Manager, indicated that your firm did not complete an audit plan and an audit report for (b)(4) as required by your firm’s procedure.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm updated its quality audit procedure to include re-audit requirements and contracted out future quality audits to an external firm beginning in (b)(4). Your firm indicated that training will be provided. Your firm also indicated that verification will be completed after the next audit. However, your firm did not provide evidence that it will complete an audit plan and audit report for (b)(4).
 
8. Failure to maintain device history records (DHRs) and to establish and maintain adequate procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, none of the twelve reviewed DHRs (four each from the three bed models Multitech 8, Varitech, and Versatech 1100 patient beds) included the primary identification label.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm updated its Medical Device Labeling Procedure to include the requirement of adding primary identification labels to DHRs. Your firm indicated that training will be provided. However, your firm did not provide evidence that the primary identification labels were included in the 12 DHRs reviewed and mentioned above and that it completed a retrospective review of all DHRs to ensure they included the primary identification label as required.
 
9. Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example, the risk analysis for Design Project 2010-01 dated July 17, 2012, was not conducted during the design development project, prior to design transfer on October 13, 2011.   
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will revise its design control procedures to include design validation requirements and provide training. However, your firm did not provide evidence of the completion of these activities. Additionally, your firm did not provide evidence that it considered a systemic corrective action to this deficiency to include a retrospective review of risk analysis activities for other devices to ensure they were completed and documented as required. 
 
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. Significant violations include, but are not limited to, the following:
 
Failure to adequately develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Procédure de rapport obligatoire,” P-8.5-2, Date de revision: 10/07/2012, Rev. 1, Approbation Date: 10/07/2012, the following issues were noted:
 
1. The procedure 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. To facilitate the correct interpretation of reportable events and to assure the quality of MDR submissions, the procedure should include definitions based on 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” “MDR reportable event,” and “serious injury,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1).
 
2. The procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example: 

a. There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event. 

b. There are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner. 

c. The procedure, as written, does not specify who makes the decision for reporting events to FDA. Although the procedure states that the “General Director of Rotec International will coordinate all the activities related to the procedure,” it is not clear if the “coordinator” is also the person responsible for making the reportability decision.   

 
3. The procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed: 

a. The circumstances under which your firm must submit initial, supplemental, and 5 day reports and the requirements for such reports. 

b. The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002

 
4. The procedure does not describe how your firm will address documentation and record-keeping requirements, including: 

a. Documentation of adverse event related information maintained as MDR event files. 

b. Information that was evaluated to determine if an event was reportable. 

c. 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. 

d. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.

 
If your firm wishes to submit MDR reports via electronic submission, it can follow the directions stated at the following URL: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the MDR Policy Branch at 301-796-6670 or by email at MDRPolicy@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.  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 actions (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 #385398 when replying. If you have any questions about the contents of this letter, please contact Carl Fischer at 301-796-5770 or 301-847-8137 (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