Avantec Vascular Corporation

Form 483FOIA Uncovered

Sunnyvale, California, United StatesFEI 3003524171Issued January 10, 2020

View FDA's Record for This Firm

Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003524171.

Observations3

Issue DateJanuary 10, 2020

StatusNo Warning Letter

Related Inspections5

Establishment Details

Firm: Avantec Vascular Corporation
Location: Sunnyvale, California, United States
FEI Number: 3003524171
Product Type: Devices
Issue Date: January 10, 2020
Country: United States

Inspection History, 2010 to 2026

NAI3

VAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

Avantec Vascular Corporation FDA Form 483, Sunnyvale, California, January 10, 2020