FDA Inspection
US Vascular, Inc.US Vascular, Inc. – FDA Inspection, Mar 28, 2016
Record Details
This FDA Inspection record concerns US Vascular, Inc., with an inspection on March 28, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- US Vascular, Inc.
- Inspection Date
- March 28, 2016
- Product Type
- Devices
View Company Profile
ID · 546e1f41-6f93-49ec-922c-76166d7fc48c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 964378
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Showing 10 of 12 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of US Vascular, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 6, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 13, 2020 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 21, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 30, 2018 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 24, 2017 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for US Vascular, Inc.
- FDA Inspection 1232207 - 2024-03-06
- FDA Inspection 1117760 - 2020-02-13
- FDA Inspection 1084664 - 2019-03-21
- FDA Inspection 1046518 - 2018-03-30
- FDA Inspection 1010050 - 2017-04-24
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.