June 30, 2014
VIA UNITED PARCEL SERVICE
David M. Sitton, Managing Director
Advanced MicroVas II LLC.
3061 West Albany
Broken Arrow, Oklahoma 74012
Dear Mr. Sitton:
During an inspection of your firm located in Broken Arrow, Oklahomaon July 9, 2013 through November 18, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a specification developer for the Micro VAS8110 devices. 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 (CFR), Part 820.
1. Failure to establish design control procedures as required by 21 CFR 820.30(a).
For example, your firm is the specification developer for the Micro VAS8110 and has not established procedures for design inputs, design outputs, design verification, design validation, design changes, or design history files.
2. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been adequately established as required by 21 CFR 820.198.
For example, your firm does not have any written procedures for receiving, reviewing, and evaluating complaints.
3. Failure to establish purchasing control procedures as required by 21 CFR 820.50.
For example, you are a specification developer for the Micro VAS8110, which you have contract manufactured. You do not have any procedures to control the evaluation of suppliers, define the type and extent of control to be exercised, or to maintain records of acceptable suppliers.
4. Quality audit procedures have not been established as required by 21 CFR 820.22.
For example, your firm has been in operation since July 2, 2012 and you have not written procedures for performing quality audits and you have not conducted any quality audits.
5. A device master record has not been maintained as required by 21 CFR 820.181.
For example, your firm has distributed approximately (b)(4) Micro VAS8110 units and your firm does not have a device master record established for this device.
Our inspection also revealed that your firm’s Micro VAS8110 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:
1. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17.
A. SOP-1012, Rev. A 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:
1. 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,” and definitions for the terms “reasonably known” and “reasonably suggests,” found respectively in 21 CFR 803.50(b) and 803.20(c)(1) 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. SOP-1012, Rev. A does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
1. How your firm will submit all information reasonably known to it for each event.
2. 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.
C. SOP-1012, Rev. A does not describe how it will address documentation and record-keeping requirements, including:
1. Documentation of adverse event related information maintained as MDR event files.
2. Information that was evaluated to determine if an event was reportable.
3. 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.
4. Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
Your firm’s procedure 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).
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
Our inspection also revealed that the Micro VAS8110 devicesare adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the devices is described on the Internet at http://www.fda.gov /MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the products may be legally marketed.
In addition, FDA has reviewed your firm’s website (www.microvas.com) as well as the brochure entitled “Advanced MicroVas II diabetic & non-diabetic peripheral neuropathy” which is used to market your devices, and determined that several intended uses associated with Micro VAS8110 devices would require substantiation through clinical data. Examples include:
Your website states “Microvas Recommended Uses” and list intended uses not limited to:
- Bone Fracture
- Carpal Tunnel Syndrome
- Decubitus Ulcers
- Diabetic Peripheral Neuropathy
- Multiple Sclerosis (MS)
- Rheumatoid Arthritis
- Spider Bite
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements for fiscal years 2013 and 2014.
Therefore all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(o)), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).
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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, 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 violations 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, 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 (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. Your firm’s response should be comprehensive and address all violations included in this Warning Letter.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility, products or websites. 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.
Reynaldo R. Rodriguez, Jr.