FDA Inspection
Addition Technology IncAddition Technology Inc – FDA Inspection, Jun 28, 2013
Record Details
This FDA Inspection record concerns Addition Technology Inc, with an inspection on June 28, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Addition Technology Inc
- Inspection Date
- June 28, 2013
- Product Type
- Devices
View Company Profile
ID · 8aaca690-f148-4507-8620-13c6703cea02
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838149
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.186QSR
- 21 CFR 820.20(c)Management review dates
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Addition Technology Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 27, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 11, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 24, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 15, 2008 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Addition Technology Inc
- FDA Inspection 1204379 - 2023-04-27
- FDA Inspection 1029535 - 2017-09-15
- FDA Inspection 942276 - 2015-09-11
- FDA Inspection 653684 - 2010-03-24
- FDA Inspection 554460 - 2008-12-15
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.