FDA Inspection
OraSure Technologies, Inc.OraSure Technologies, Inc. – FDA Inspection, Aug 25, 2015
Record Details
This FDA Inspection record concerns OraSure Technologies, Inc., with an inspection on August 25, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- OraSure Technologies, Inc.
- Inspection Date
- August 25, 2015
- Product Type
- Devices
View Company Profile
ID · eb47874b-4605-40ef-9820-00cef930286b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 939374
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
1- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OraSure Technologies, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 9, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 24, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for OraSure Technologies, Inc.
- FDA Inspection 1046324 - 2018-03-09
- FDA Inspection 777546 - 2012-05-24
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