Dive Brief:

• FDA has issued a warning letter to US Vascular after the manufacturer of vascular pathology devices failed to address inspector observations dating back two years.

• The warning letter takes US Vascular to task for failing to establish procedures for complaints, quality audits, design control and other activities.

• In many cases, US Vascular told the inspectors the procedures became effective on the day of their visit, but was unable to provide evidence of the review or approval of the documents.

Dive Insight:

US Vascular has been in FDA's crosshairs for several years. FDA inspectors visited the Oregon facility where US Vascular makes Class II VascuLab vascular pathology devices in 2016, 2017 and 2018. Eight of the citations US Vascular received in 2016 were repeated in the 2018 inspection. Eleven of the 12 citations FDA issued in the 2018 were repeat observations from its visit the previous year.

Other patterns emerge across the 12 citations made in the warning letter. FDA began its inspection of the facility on March 26. For eight of the 12 areas of FDA concern, US Vascular told inspectors it had brought a procedure addressing the issue into force on March 26, the day of their visit.

US Vascular was unable to provide evidence to support these claims, though. Throughout the letter, FDA states it found no documented effective date or evidence of review or approval for US Vascular's procedures. As US Vascular claimed the procedures had just become effective, they were yet to be used in the compiling of device master records, internal audits and the other processes they cover.

In each case, US Vascular told FDA it would implement the newly-effective procedures in the coming months. However, FDA said it was unable to tell whether US Vascular's response was adequate as the company had not provided any objective evidence of corrections at the time of the June warning.

US Vascular's track record looks to have counted against it in FDA's assessment of the adequacy of the responses. The warning letter repeatedly refers to prior interactions between FDA and US Vascular about the observations made during the most recent inspection. For many of the current observations, US Vascular told FDA about its planned corrective actions in April and August of 2017.

The warning letter sets out the work US Vascular needs to do to address FDA's concerns. The list of tasks includes the creation of regulatory-compliant procedures for handling complaints and the documentation of design changes. US Vascular could face seizure, injunction and money penalties if it fails to address the observations.

"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," the warning letter states.