- Ferrosan Medical Devices A/s
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
White Oak Building 66
Silver Spring, MD 20993
SEP 16, 2015
VIA UNITED PARCEL SERVICE
Mr. Henrik Krois
Ferrosan Medical Devices A/S
Dear Mr. Krois:
During an inspection of your firm located in Soeborg, Denmark,on April 27, 2015, through April 30, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the Surgioflo Hemostatic Matrix, an absorbable hemostatic, collagen based device. 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.
Our inspection revealed that your firm's absorbable hemostatic, collagen based 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.
We received a response from your firm dated May 7, 2015, concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional Observations, which was issued to your firm. We address this response below, in relation to each of the noted violations. Significant violations include, but are not limited to, the following:
Failure to submit a report to the FDA no later than 30 calendar days after the day that your firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a death or serious injury,as required by 21 CFR 803.50(a)(1).
For example, Complaint #200062395 references an event that associates your firm's Surgiflo device with an event that may have caused or contributed to a patient's death and therefore, an MDR should have been submitted within the 30 calendar day timeframe. Your firm became aware of the event on August 29, 2012. As of the time of your firm's response, FDA has not received an MDR for the referenced event.
We reviewed your firm's response and conclude that it is not adequate. We have not received a report for the MDR reportable event referenced in Complaint #200062395. In addition, your firm's revised MDR procedure titled "Medical Device Reporting," No. 10880, Issue Date: 28.04.2015, is not adequate. After reviewing your firm's MDR procedure, the following issues were noted:
1. Your firm's 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:
a. The procedure omits the definition of the term "reasonably suggests," found in 803.20(c)(1). The exclusion of the definition for this term from the procedure 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).
b. The procedure states that "(b)(4)." Your firm should submit one report for each patient involved in the event, and for each separate event.
2. Your firm's 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, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
3. Your firm's procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
a. The procedure includes references to the FDA 3500A form and instructions, but still does not link the references to the appropriate FDA websites. We recommend including the following links:
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.
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirement of this final rule has taken 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/Forlndustrv/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.
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.
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 (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 response 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 #474404 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (240) 402-4020 (phone), or +1 (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 lnspectional 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.
Jan Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and Radiological Health
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