Inspections, Compliance, Enforcement, and Criminal Investigations

Conkin Surgical Instruments Ltd. 1/12/15

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993 

 

WARNING LETTER
JAN 12, 2015 
 
VIA UNITED PARCEL SERVICE
 
Konstantin Valtchev, M.D.
Owner
Conkin Surgical Instruments Ltd.
30 Lesmill Road, Unit 4
Toronto, Ontario M3B2T1
Canada
 
Dear Dr. Valtchev:
 
During an inspection of your firm located in Toronto, Ontario, Canada, on September 8, 2014, through September 11, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Valtchev Uterine Mobilizer. 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.
 
This inspection revealed that this device is 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, its 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 October 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:
 
1.    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 corrective and preventive action (CAPA) procedures do not include requirements for analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, and verifying and validating corrective and preventive actions.
 
2.    Failure to document corrective and preventive actions, and their results, as required by 21 CFR 820.100(b). For example, CAPA investigations and verifications of CAPA effectiveness were not adequately documented for Nonconformance Reports dated August 12, 2008, January 11, 2013, and April 10, 2014.
 
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  does not ensure that complaints are processed in a uniform and timely manner. Also, your firm’s procedure does not ensure that any complaint involving the possible failure of a device, labeling, or packaging to meet any of its specifications will be reviewed, evaluated, and investigated, unless such investigation has already been performed for a similar complaint and another investigation is not necessary. Additionally, your firm failed to consider unscheduled repairs of Valtchev Uterine Mobilizers returned by customers as complaints.
 
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 failed to document design changes to the Valtchev Uterine Mobilizer, according to your firm’s procedure.
 
5.    Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm’s acceptance procedure for incoming product does not describe acceptance criteria or test procedures.
 
6.    Failure to establish and maintain procedures for finished device acceptance to ensure that each production run, lot, or batch of finished devices meets acceptance criteria, as required by 21 CFR 820.80(d). For example, your firm’s document, “Final Inspection Checklists,” shows that a leak test is performed as part of final acceptance and release activities; however, there is no corresponding documented test procedure.
 
7.    Failure to document acceptance activities, as required by 21 CFR 820.80(e). For example, material acceptance records for three purchase orders do not document inspection sample sizes, types of inspections, and inspection results. Additionally, incoming inspection of the Space Bar for the Valtchev Uterine Mobilizer 6  is not documented.
 
8.    Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120. For example, your firm’s labeling procedure  does not include requirements to assure that labeling has been examined for accuracy, by a designated individual prior to storage or use, and that the release of labeling is documented. 
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm addressed all the violations listed by providing a root cause analysis; however, your firm’s response did not include documentation of corrections to address an immediate cause, or corrective actions that address systemic problems.
 
Our inspection also revealed that the Valtchev Uterine Mobilizer ismisbranded 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). These violations include, but are not limited to, the following:
 
9.    Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm’s procedure does not establish internal systems that provide for:
 
a.    Timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
 
b.    A standardized review process to determine when an event meets the criteria for reporting under 21 CFR Part 803; and
 
c.    Timely transmission of complete MDRs or describe how your firm will address documentation and record-keeping requirements.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm's response did not include a copy of an MDR procedure. In order to determine adequacy, FDA must receive a copy of your firm’s MDR procedure for review.
 
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.
 
Given the serious nature of the violations of the Act, Valtchev Uterine Mobilizersmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
 
Also, 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. 
 
Please notify this office in writing, within fifteen business days from the date you receive this letter, of the specific steps that our 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 (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.  Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
 
Your firm’s response 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 #443059 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 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

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