FDA Inspection
Circulatory Technology Inc.Circulatory Technology Inc. – FDA Inspection, Mar 15, 2010
Record Details
This FDA Inspection record concerns Circulatory Technology Inc., with an inspection on March 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Circulatory Technology Inc.
- Inspection Date
- March 15, 2010
- Product Type
- Devices
View Company Profile
ID · e53154d4-71ca-4b1f-986d-365e7a344834
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 652147
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.198(a)General
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Circulatory Technology Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 26, 2018 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 8, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 31, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 11, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Circulatory Technology Inc.
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.