FDA Inspection
Defibtech, LLCDefibtech, LLC – FDA Inspection, Feb 8, 2011
Record Details
This FDA Inspection record concerns Defibtech, LLC, with an inspection on February 8, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Defibtech, LLC
- Inspection Date
- February 8, 2011
- Product Type
- Devices
View Company Profile
ID · 1483d6b5-3b1f-452c-9aec-9256e9c56b43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708589
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Defibtech, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 16, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 25, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 21, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 18, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Defibtech, LLC
- FDA Inspection 1024269 - 2017-08-16
- FDA Inspection 876495 - 2014-04-25
- FDA Inspection 760057 - 2011-12-21
- FDA Inspection 675878 - 2010-08-18
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.