- ARB Medical, LLC
- Issuing Office:
- Minneapolis District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 334-4100FAX: (612) 334-4142
December 22, 2015
Via UPS Overnight Delivery
Refer to MIN 16 – 04
Michael R. Afremov
Chief Executive Officer
ARB Medical, LLC
601 Carlson Parkway, #550
Minnetonka, Minnesota 55305
Dear Mr. Afremov:
During an inspection of your firm located at 5929 Baker Road, Suite 470, Minnetonka, Minnesota, on August 5 through 11, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures polymeric surgical meshes. 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 any 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 (21 CFR), Part 820. Violations revealed during the inspection include, but are not limited to, the following:
1. Failure to adequately validate, according to established procedures, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). Specifically, process validation was not conducted for the (b)(4) operation used to (b)(4). Further, the qualification study performed by the (b)(4) supplier does not vary parameters of the (b)(4) process and instead involves (b)(4).
2. Failure to review and approve design output before release, as required by 21 CFR 820.30(d). Specifically, critical product characteristics of the polypropylene and PTFE surgical meshes were not reviewed and approved before release. These surgical meshes are used in your Rebound HRD and HRD-V devices, respectively. For example, characteristics that are critical for surgical meshes such as mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pull-out strength, burst strength, and tear resistance were not tested by your firm prior to shipment of the finished devices.
3. Design validation failed to ensure the device conforms to defined user needs and intended uses, as required by 21 CFR 820.30(g). Specifically, testing was not performed to show the device met design input requirements, including characteristics that are critical for surgical meshes: mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pull-out strength, and tear resistance.
4. Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). Specifically, the specifications contained in the supplier agreements for polypropylene and PTFE mesh components do not match design output requirements for characteristics that are critical for surgical meshes: mesh thickness, mesh weave characteristics, pore size, mesh density, tensile strength, device stiffness, suture pull-out strength, burst strength, and tear resistance.
5. Failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). Specifically, your Complaint Handling Procedure (SOP #026, Rev. D) requires complaint investigations when you receive any report involving the possible failure of a device to meet its performance specifications, or a potential serious injury or a malfunction that could have resulted in a serious injury. Further, your procedure states that care must be taken to ensure that all information on the form is correct, factual, and legible, and as much data as possible should be recorded. Additionally, QA shall review the FER to determine if the event needs to be reported to FDA and the results of the review will be documented in the regulatory section of the FER form. However, investigations were not conducted and information is not documented on the complaint form, as required by your procedure. For example:
A. Complaint FER-010 was received on 4/28/15 with the form populated with “Unknown” in the catalog # field. This information is within the remainder of the complaint file, but not documented as required by your procedure. Additionally, there is no justification for why no MDR was filed, as is required by your procedure.
B. Complaint FER-009 was received on 9/26/14 for patient report of pain. An investigation was not conducted. The complaint investigation section states “no investigation warranted” with justification “no additional information has been received” although the original e-mail contains information about a surgery to remove the end of the nitinol wire which was piercing the muscles at the end of the broken ring. Additionally, there is no justification for why no MDR was filed, as is required by your procedure.
C. Complaint FER-008 was received on 10/26/12 for patient discomfort approximately eight months after implantation. The physician removed the device and upon removal it was observed that the device had a broken cable. Your firm did not investigate this complaint.
6. Failure to adequately establish procedure for corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, your Corrective and Preventive Action procedure (SOP #015, Rev. E) defines a corrective action as one taken to correct a deficiency, where a deficiency is the failure of a product to meet established quality standards. However, a CAPA was not opened to document the actions taken to correct and prevent the separation of the nitinol cable in devices as reported in complaint record FER-004. Actions included the (b)(4). Additionally, the decision to (b)(4), including the reason for (b)(4) is not documented in any other system (e.g., change control or nonconforming material report).
Our inspection also revealed that your firm’s Rebound HRD Mesh 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 regarding this 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 deviations include, but are not limited to:
7. Failure to report to 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 your firm markets has malfunctioned and this device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).
For example, Complaints FER-10, FER-008, and FER-006 describe a malfunction of your firm’s long term implantable device. As a result of the malfunction, the patient had to undergo revision surgery that resulted in the removal of the device or removal of a portion of the device. Your firm should have submitted a MDR for each of the above referenced complaints.
8. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17(a)(1). For example, your firm’s MDR procedure entitled “US FDA Medical Device Reporting Procedure,” SOP #028, Rev. C, does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. Specifically, the procedure omits the definition of the term “reasonably suggests,” found in 803.20(c)(1). The exclusion of this 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).
Please note that SOP #028, Rev. C, page 6, states that MDRs are sent to the FDA via mail or fax. Effective August 14, 2015, MDRs should be submitted to the FDA in an electronic format that the FDA can process, review and archive. Paper submissions will not be accepted, except under special circumstances directed by the FDA. Your firm should adjust its MDR procedure accordingly to include a process for submitting MDRs electronically in accordance with the Final Rule for electronic Medical Device Reporting (eMDR) published in the Federal Register on February 14, 2014. In addition, your firm will need to establish an eMDR account in order to submit MDRs electronically. Information about the Final Rule for eMDR and the eMDR set-up process can be found on the FDA website at:
Also, SOP #028, Rev. C, includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
Your firm should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all 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 15 working days from the date you receive this letter with an update on the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective actions you have taken. If your planned corrections will occur over time, please include a timetable for implementation. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Melissa I. Michurski, Compliance Officer, at the address on this letterhead. Refer to the Unique Identification Number (CMS case #482215) when replying. If you have any questions about the content of this letter please contact Ms. Michurski at (612) 758-7185.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483, issued at the close-out of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations and take prompt action to correct the violations and to bring your products into compliance.
Michael Dutcher, DVM
xc: David E. Bakken
Director of Operations
ARB Medical, LLC
5929 Baker Road, Suite 470
Minnetonka, MN 55345