FDA Inspection
Quidel CorporationQuidel Corporation – FDA Inspection, Jan 29, 2018
Record Details
This FDA Inspection record concerns Quidel Corporation, with an inspection on January 29, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ff55cd9d-e991-42f6-af52-85cb4fd8c2c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1041292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 806.10(a)(2)Report of violation of the Act (see 803.52(e)(9))
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Quidel Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 3, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 21, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 17, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 16, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 24, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Quidel Corporation
- FDA Inspection 1149132 - 2021-08-03
- FDA Inspection 834600 - 2013-05-21
- FDA Inspection 816786 - 2013-01-17
- FDA Inspection 715087 - 2011-03-16
- FDA Inspection 614117 - 2009-09-24
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