FDA Flags Spate of GMP Violations at US Vascular
US Food and Drug Administration (FDA) investigators revealed 11 violations of good manufacturing practices (GMP) during a March site inspection at US Vascular’s medical device manufacturing facility in Beaverton, OR, according to an FDA warning letter.Out of 12 inspectional citations first noted in an FDA Form 483, the agency investigators flagged 11 repeat observations from the firm’s previous site inspection in April 2017. “Eight of the citations you received in the recent inspection were also repeated from the March 2016 inspection,” FDA said.
The 483 observations became significant GMP violations with the issuance of the warning letter. GMP violations cited in the warning letter issued to US Vascular, a manufacturer of Class II vascular pathology devices, relate to inadequate procedures for design control, complaint handling, implementing corrective and preventive actions (CAPAs), design changes, supplier evaluation and controlling nonconforming products, as well as maintaining a device master record and device history records.
The firm was also cited for lacking procedures for accepting incoming products, document control and conducting internal quality audits, according to the warning letter. It attempted to ease FDA’s concerns by claiming to have implemented new procedures on the same day the agency’s site inspection was initiated. These include the firm’s procedures for supplier evaluation and for document control.
Further, the firm had yet to implement certain adverse event reporting procedures at the time of FDA’s visit. FDA previously informed the firm of a requirement to include reviews for medical device reporting under 21 CFR Part 803 or 21 CFR Part 820.198 “via citation on the FDA Form 483 during your last three inspections,” the agency said. “Adequate corrections have not been received by the agency to date.”
FDA intends to review the firm’s actions to address each of the violations as part of its next inspection.
US Vascular LLC 6/7/18