Company
United StatesPublic company, NASDAQ: OSUROraSure Technologies, Inc. (NASDAQ: OSUR), Bethlehem, PA – FDA Inspections
Inspection records and compliance data for OraSure Technologies, Inc. in Bethlehem, Pennsylvania. 7 FDA inspections on record, last inspected December 13, 2018. Publicly traded as NASDAQ: OSUR.
Company Profile
This profile covers OraSure Technologies, Inc. based in Bethlehem, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected January 27, 2009. Last inspected December 13, 2018.
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 13, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1077597 |
| September 9, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 939652 |
| May 30, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 783435 |
| April 17, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 777358 |
| November 3, 2011 | NAI | Biologics · Bioresearch Monitoring | 752299 |
| March 31, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 653459 |
| January 27, 2009 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 559226 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
OraSure Technologies, Inc.
Stock ticker
OSUR
Exchange
NASDAQ
Share price
$3.38
Market cap
$232.8M
Price as of
November 6, 2026
FEI Number
3004142665
Address
220 E 1st St, Bethlehem, Pennsylvania 18015, United States
Country
United States
ID: 720b9d90-ff16-477c-a8a1-57eaac2aac4b