Company
United StatesQuidel Corporation, Athens, OH – FDA Inspections
Inspection records and compliance data for Quidel Corporation in Athens, Ohio. 6 FDA inspections on record, 1 Form 483, last inspected August 03, 2021.
Company Profile
This profile covers Quidel Corporation based in Athens, Ohio, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 1
- Warning letters
- 0
First inspected September 24, 2009. Last inspected August 3, 2021.
Most cited issue areas
- Calibration, Inspection, etc. Procedures Lack of or Inadequ1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 3, 2021 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1149132 |
| January 29, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1041292 |
| May 21, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 834600 |
| January 17, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 816786 |
| March 16, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 715087 |
| September 24, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 614117 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Quidel Corporation
FEI Number
1000122536
Address
2005 E State St Ste 100, Athens, Ohio 45701, United States
Country
United States
ID: a4399182-31b3-4c3e-9cee-eb0c4628baaa