US Vascular LLC - 554761 - 06/07/2018

WARNING LETTER

CMS # 554761

UNITED PARCEL SERVICE

OVERNIGHT DELIVERY

June 7, 2018

US Vascular, LLC

Galen T. Spooner, Owner

15246 NW Greenbrier Pkwy, Mailbox #9

Beaverton, OR 97006

Dear Mr. Spooner:

The United States Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at 15246 NW Greenbrier Pkwy, Beaverton, OR from March 26 – 30, 2018. During the inspection, an FDA investigator determined that your firm is a manufacturer of the Class II VascuLab devices used in vascular pathology. 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.

We received a response dated April 13, 2018 from your firm concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations (FDA 483) that was issued on March 30, 2018. Historically, you have promised corrections and to date, adequate corrections have not been observed even after you purchased procedures which were never fully implemented in the past. It is also of note that 11 of 12 citations received in your most recent inspection were repeat citations from the April 2017 inspection. Eight of the citations you received in the recent inspection were also repeated from the March 2016 inspection. We address your response below, in relation to each of the noted violations. For your reference, FDA defines “establish” under 21 CFR Part 820.3(k) as “define, document (in writing or electronically), and implement.” These violations include, but are not limited to, the following:

1. Procedures for design control have not been established per the requirements of 21 CFR Part 820.30.

You provided a Design and Development procedure during our recent inspection, SOP-03, Rev 1. This procedure does not note any effective or implementation date, or any evidence it has been reviewed or approved yet you told our investigator it became effective on March 26, 2018, and that it was in the process of being implemented. This procedure requires design verification to demonstrate design outputs meet design inputs, and that design verification provides objective evidence. It also requires design validation to demonstrate the device meets user needs and to provide objective evidence.

You also provided a “(b)(4)” for the (b)(4). There is no effective date on this document, and the only date noted reflects “As Of: March 27, 2018 9:20 PM”, or the second day of our inspection. This document shows that design outputs are missing for at least 13 design inputs including functions of the (b)(4) and the (b)(4) of the device. It also shows that outputs were not verified or validated for at least (b)(4) inputs including those related to the (b)(4) for this vascular pathology ultrasound device.

Your recent response states you will review the Design procedure and (b)(4) and perform gap analysis on the DHF to update any missing files. You provided an estimated completion date of July 31, 2018; however, the adequacy of your firm’s response cannot be determined at this time as you have not provided any objective evidence of corrections to date. You also promised corrections to a similar observation in annotation to your April 2017 FDA Form 483, and further stated corrections would be completed within approximately two months of your August 22, 2017 Regulatory Meeting. Your response also fails to address the reason you did not correct this violation after we brought it to your attention multiple times (in our letters dated 11/17/2016, 5/31/2016, FDA Form 483 dated 3/28/2016, and FDA Additional Information Request dated 8/22/2013). Adequate corrections have not been received by the Agency to date.

We request that you review 21 CFR Part 820.30 and provide documentation showing the updated (b)(4) once the gap analysis is complete and inform our office when all items are corrected and in compliance. These will be further reviewed as part of your next inspection.

2. Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have not been established per the requirements of 21 CFR Part 820.198.

During our recent inspection, no procedure governing complaint handling could be provided; however, your firm has received complaints via email. These complaint records could also not be provided to our investigator aside from a single example. The example provided did not include required information per 820.198 and the content of the complaint itself was unclear since only the email was provided and no further documentation was performed to meet the requirements of the regulation.

Your recent response states you plan to implement a complaint handling procedure and evaluate complaints as necessary by May 31, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you stated you wanted to integrate complaint handling with your CAPA system but did not provide a potential timeframe for correction. Adequate corrections have not been received by the Agency to date.

Your firm should review the requirements of 21 CFR Part 820.198 and establish a procedure to meet these regulatory requirements. We request that you notify our office when this procedure has been established and implemented and provide a copy of the procedure. Your procedure should include how you will keep complaint files organized so they are readily accessible during your next inspection. Once you have developed this procedure, we request that you utilize it to provide our office with additional explanation regarding the complaint that was collected during the inspection. Please provide thorough explanation of the (b)(4) issue, your investigation, and address whether the fix was made to the single device of the complainant or made to all devices in the field, as well as how the fix was implemented (software update, physical hardware change, etc.).

3. Procedures for corrective and preventive action have not been established per the requirements of 21 CFR Part 820.100.

During our recent inspection, you provided a Corrective & Preventive Action, SOP-11, Rev 1. However, similar to other procedures provided, this procedure does not note any effective or implementation date or evidence of review or approval, yet you told our investigator it became effective on March 26, 2018. You also told our investigator this procedure has not been implemented yet. At the time of our inspection, your firm had not initiated any CAPAs since the last inspection.

Review of the supplied procedure found it addresses (b)(4). The procedure does not address the requirement to verify or validate corrective or preventative actions to ensure the actions do not adversely affect the finished device. We request that you review this procedure to ensure it meets all requirements of 21 CFR Part 820.100 and that you have the required personnel on board to comply with your own requirements (or update those requirements to fit your current operations).

Your recent response states you plan to implement the CAPA procedure and initiate and complete CAPAs as necessary by April 30, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you stated you wanted to (b)(4) but did not provide a potential timeframe for correction. Adequate corrections have not been received by the Agency to date.

We request that you review the requirements of 21 CFR Part 820.100 and notify our office when your procedure meets all requirements and has been implemented. CAPA procedures and records will be reviewed as part of your next inspection.

4. Procedures for design change have not been established per the requirements of 21 CFR Part 820.30(i).

You provided a Design and Development procedure during our March 2018 inspection, SOP-03, Rev 1, as discussed in item 1. This procedure requires design changes to be reviewed (b)(4).

During our recent inspection, you told our investigator (b)(4) have been made to the (b)(4) that controls the VascuLab device. You stated these changes included (b)(4) to correct errors in the initial board design. During the inspection, you could not provide any documented evaluation of the changes, potential effect of the changes, documentation of verification testing, etc.

Your recent response indicates you plan to update your procedures and evaluate past design changes by June 30, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. In addition, your response does not address products in the field with these initial design differences in (b)(4). After you have reviewed your procedure against the regulatory requirements, please assess the impact of this change and provide our office details of whether or not those devices in the field with the initial (b)(4) may result in device failure.

You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and additionally when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you stated you weren’t sure of when the item could be corrected, possibly within two months. Adequate corrections have not been received by the Agency to date. We have included an FDA guidance document titled “Design Control Guidance for Medical Device Manufacturers” to assist in your corrections.

We request that you review 21 CFR Part 820.30 and provide us the date when design changes have been documented according to the requirements of the regulation. These will be reviewed as part of your next inspection.

5. Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been established per the requirements of 21 CFR Part 820.50.

You provided a Supplier Evaluation procedure during our inspection, SOP-05, Rev 1. This procedure does not note any effective or implementation date and does not show it has been reviewed or approved, yet you told our investigator it became effective the day our inspection was initiated, March 26, 2018. This procedure requires the qualification, evaluation, and monitoring of suppliers of goods and services impacting product quality and states approved suppliers should be maintained on your firm’s (b)(4).

During our recent inspection, you could not provide documentation showing the supplier for your (b)(4), or any other suppliers for the VascuLab device, have been evaluated or approved. You stated your firm is in the process of creating the (b)(4) and could not provide one to our investigator.

Your recent response states you plan to implement your procedure(s), review and update supplier files, and implement your (b)(4) by June 30, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483 and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, at which time you stated you needed to discuss it with your consultant. Adequate corrections have not been received by the Agency to date.

Please be aware in your review of 21 CFR Part 820.50 that the regulation also applies to consultants. We request that you review the requirements of this part and notify our office when your (b)(4) and the corresponding evaluations and documentation are complete to meet the regulatory requirements. These will be reviewed as part of your next inspection.

6. Procedures for acceptance activities have not been established per the requirements of 21 CFR Part 820.80.

You provided examples of (b)(4) for your VascuLab devices during our recent inspection; however, you stated your firm does not have any documented procedure that governs how these tests are performed. The results include (b)(4).

You told our investigator that you have distributed approximately (b)(4) VascuLab vascular pathology ultrasound transducers since your last inspection. Your recent response states you plan to implement receiving inspection procedures, establish sampling plans, and establish testing and finished product release procedures by May 31, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. The history of your firm shows this citation has been received in your last two FDA Form 483s, both of which you annotated that you “promised to correct” this issue. During your August 22, 2017 Regulatory Meeting you stated you would correct this deficiency within approximately one month. Adequate corrections have not been received by the Agency to date.

We request that you review 21 CFR Part 820.80 and notify our office once the corresponding procedure(s) have been fully established including implementation in your firm’s records. These will be reviewed as part of your next inspection.

7. Procedures have not been established to control product that does not conform to specified requirements per the requirements of 21 CFR Part 820.90.

During the recent inspection, our investigator observed what you described as nonconforming VascuLab components in a segregated area, but you could not provide any nonconformance records to show the type of nonconformance, any corresponding investigation, or disposition of these items. You provided a Nonconforming Material procedure, SOP-10, rev 1, to our investigator. However, similar to other procedures provided, this procedure does not note any effective or implementation date or evidence or review or approval, yet you told our investigator it became effective on March 26, 2018. You also told our investigator this procedure has not been implemented yet.

Your recent response states you plan to implement your Nonconforming Material procedure and evaluate all open nonconformances according to the procedure by May 31, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was

discussed during your firm’s August 22, 2017 Regulatory Meeting, you estimated it would be corrected within two months. Adequate corrections have not been received by the Agency to date.

Review of your Nonconforming Material procedure, SOP-10, rev 1, found the procedure requires (b)(4). We request that you review this procedure to ensure it meets all requirements of 21 CFR Part 820.90 and that you have the required personnel on board to comply with your own requirements (or update those requirements to fit your current operation). We request that you notify our office when the procedure has been fully implemented including recording nonconformance records as appropriate. These will be reviewed as part of your next inspection.

8. A device master record has not been maintained per the requirements of 21 CFR Part 820.181.

During our recent inspection, you could not provide a Device Master Record (DMR) for the VascuLab device, and you asked our investigator what a DMR is. After some explanation by our investigator, you provided a procedure titled Device Master Record, SOP-09, Rev 1, and stated it became effective on March 26, 2018. However, similar to other procedures provided, this procedure does not note any effective or implementation date or evidence or review or approval. You also told our investigator this procedure has not been implemented yet but would be used to compile a future DMR.

Your recent response states you plan to implement your DMR procedure and create the DMR by June 30, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you estimated it would be corrected within two months. Adequate corrections have not been received by the Agency to date.

We request that you review the requirements of 21 CFR Part 820.181 to ensure your procedure meets all requirements, and notify our office when the procedure has been fully implemented and the DMR is complete. This will be reviewed as part of your next inspection.

9. Document control procedures have not been established per the requirements of 21 CFR Part 820.40.

During our recent inspection, procedures provided (including SOPs 1, 2, 3, 5, 10, 11, and 14) did not include documented effective dates, or evidence they had been reviewed and approved. You stated these procedures became effective on March 26, 2018, the same day our inspection was initiated.

Review of the supplied Document Control & Records Management procedure, SOP-01, Rev 1, found responsibilities are delineated (b)(4). The document also states your firm will use your (b)(4) for document management, and include a formal review and approval process to include records of document approvers and a published revision history. In addition, the procedure states that (b)(4) is not defined within the procedure. The procedures provided during our inspection do not follow the requirements of your document control procedure.

Your recent response states you plan to implement the Document Control procedure by April 30, 2018 and conduct review and approval for other procedures by May 31, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last two inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you stated corrections were underway with an unknown timeframe of completion. Adequate corrections have not been received by the Agency to date.

We request that you review the requirements of 21 CFR Part 820.40 against your procedure to ensure all requirements are met and your procedure can be performed as written by your organization with your current staffing (or that you update as necessary to reflect your operations). Please notify our office when your procedures have been fully reviewed to include documented approval and implemented so they may be reviewed during your next inspection.

10. Procedures for device history records have not been established per the requirements of 21 CFR 820.184.

During our recent inspection, you could not provide an established procedure that governs how Device History Records (DHRs) are maintained; however, your firm does keep some test records on hand as well as a duplicate label for your Class II VascuLab devices used in vascular pathology. The records retained do not meet the requirements of 21 CFR Part 820.184.

Your recent response states you understand the need to create a DHR procedure and plan to implement one by May 31, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you stated you needed to further research the requirements. Adequate corrections have not been received by the Agency to date.

We request that you review the requirements of 21 CFR Part 820.184 and establish a procedure to meet these requirements. Please notify our office when this procedure has been implemented; complete DHR records will need to be reviewed as part of your next inspection.

11. Procedures for quality audits have not been established per the requirements of 21 CFR 820.22.

During our recent inspection, you provided an Internal Audit procedure, SOP-22, Rev 1. However, similar to other procedures provided, this procedure does not note any effective or implementation date and does not show documentation it has been reviewed or approved, yet you told our investigator it became effective on March 26, 2018. Review of this procedure found it requires (b)(4). You told our investigator this procedure has not been implemented and no internal audits have been conducted to date.

Your recent response states you plan to implement your procedure and conduct a quality audit by April 30, 2018 as well as implement related subsequent updates to the Quality System as required based on audit findings by August 31, 2018. However, the adequacy of your firm’s response cannot be determined at this time since you have not provided any objective evidence of corrections to date. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this same observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting, you stated you would have an internal audit performed by an outside consultant but did not provide a timeframe. Adequate corrections have not been received by the Agency to date.

We request that you review the requirements of 21 CFR Part 820.22 to ensure your procedure meets all regulatory requirements, and also review your procedure to ensure you have the appropriate personnel on board to meet your internal requirements (and update these if necessary to correspond with your current operations). Please provide us a date when your first audit has been completed and be prepared to show evidence of the audit (but not the results) during your next inspection.

Our inspection also revealed that your firm’s Class II VascuLab devices used in vascular pathology 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. Written MDR procedures have not been implemented per the requirements of 21 CFR 803.17.

During our recent inspection, you provided your Adverse Event Reporting procedure, SOP-14, Rev 1, and (b)(4), both of which have no documented effective date or evidence of review or approval. You told our investigator these became effective on March 26, 2018, and neither had been implemented prior to our inspection. No complaints reviewed during our inspection included review for Medical Device Reporting under 21 CFR Part 803 or 21 CFR Part 820.198.

Your recent response does not address this observation from the FDA Form 483 issued at the end of the current inspection. Your firm has been notified of this requirement via citation on the FDA Form 483 during your last three inspections. You also promised corrections to this observation in the annotation to your April 2017 FDA Form 483, and when this was discussed during your firm’s August 22, 2017 Regulatory Meeting you stated you were looking for software to handle Medical Device Reporting but did not provide a timeframe. Adequate corrections have not been received by the Agency to date.

We request that you review the requirements of 21 CFR Part 803 and ensure your procedure meets these requirements. Please notify our office when complaints begin to be evaluated for Medical Device Reporting according to the regulations so these may be reviewed as part of your next inspection.

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 (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.

If you have questions regarding any issues in this letter, please contact Compliance Officer, Lauren Priest at 303-236-9663 or at Lauren.Priest@fda.hhs.gov. Please send your reply electronically to Kelly Sheppard, Director of Compliance Branch, at oradevices3firmresponse@fda.hhs.gov.

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,

/S/

Shari J. Shambaugh

Program Division Director

Office of Medical Device and Radiological Health

Division 3/West

U.S. Food and Drug Administration

US Vascular LLC MARCS-CMS 554761 — June 07, 2018