Inspections, Compliance, Enforcement, and Criminal Investigations

MedX Health Corp 9/11/14

  

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 11, 2014 
 
VIA UNITED PARCEL SERVICE
 
Mr. Robert G. von der Porten
President
MedX Health Corp.
1495 Bonhill Road, Unit #1
Mississauga, Ontario
L5T 1M2
Canada
 
Dear Mr. von der Porten:
 
During an inspection of your firm located in Mississauga, Ontario, Canada, on June 9, 2014, through June 11, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the SIAscopy Optical Biopsy Scanner. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.
 
Our inspection revealed that the SIAscopy Optical Biopsy Scanner is 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).  
 
We received your response dated July 3, 2014, 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 this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.  
 
For example, after conducting the review of your firm’s MDR procedure titled, “Incident Reporting, Advisory Notices, & Recalls, (b)(4), Rev. (b)(4),” dated December 12, 2011, the following issues were noted:
 
1.    (b)(4), Rev. (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: 
 
a.    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).
 
2.    (b)(4), Rev. (b)(4), 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, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 
3.    (b)(4), Rev. (b)(4), does not establish internal systems that provide for timely transmission of complete MDRs. Specifically, the following are not addressed:
 
a.    Instructions for how to obtain and complete the FDA 3500A form;
 
b.    The circumstances under which your firm must submit supplemental reports and the requirements for those reports;
 
c.    The circumstances under which your firm must submit 5-day reports when FDA has made a written request, as required by 21 CFR 803.53(b); and
  
d.    The address for where to submit MDR reports:  FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm submitted a revised MDR procedure titled, “Incident Reporting, Advisory Notices, & Recalls, (b)(4), Rev. (b)(4), dated June 18, 2014. A review of the MDR procedure was conducted.  The following issues were still noted:
 
1.    (b)(4), Rev. (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 for 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).
 
2.    (b)(4), Rev. (b)(4), does not establish internal systems that provide for timely transmission of complete MDRs.  Specifically, the following are not addressed:
 
a.    Instructions for how to obtain and complete the FDA 3500A form;
 
b.    The circumstances under which your firm must submit supplemental reports and the requirements for those reports;
 
c.    The circumstances under which your firm must submit 5-day reports when FDA has made a written request, as required by 21 CFR 803.53(b); and
 
d.    The address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002.
 
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:  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 Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov.
 
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 awarding of contracts.  
 
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, as well as 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. Please provide a translation of documentation not in English to facilitate our review.
  
In addition, FDA has noted nonconformances with regards to section 501(h) of the Act, 21 U.S.C. § 351(h), which are deficiencies within your firm’s quality system pertaining to current good manufacturing practice requirements specified in the Quality System regulation found at 21 CFR Part 820. These nonconformances include, but are not limited to, the following:
 
1.    Failure to maintain device history records (DHRs) and to establish and maintain procedures to ensure that DHRs for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the Device Master Record (DMR) and the requirements of this part, as required by 21 CFR 820.184. 
 
For example, your firm does not have DHR procedures. Additionally, your firm’s DHRs for the SIAscopy Optical Biopsy Scanner (Quality Inspection Checklists – SIAscopes Kits for S/N MH000031-MH000037) did not include dates of manufacture and acceptance records.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm’s procedure titled, “Production, (b)(4), Rev. (b)(4),” dated June 16, 2014, provides DHR maintenance requirements. Your firm provided a DHR in accordance with the revised procedure (Inspection & Test Record (b)(4)). However, your firm did not indicate that it conducted training on the revised procedure.
 
Your firm’s response to this letter 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 #438242 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 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

Page Last Updated: 03/24/2015
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