FDA Inspection
Apira Science, Inc.Apira Science, Inc. – FDA Inspection, Nov 7, 2017
Record Details
This FDA Inspection record concerns Apira Science, Inc., with an inspection on November 7, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · fcfe141b-5f98-4f0c-b4e9-2ff5545a3866
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031341
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.30(h)Incorrect translation to production specifications
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Apira Science, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2022 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 13, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 20, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 29, 2011 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Apira Science, Inc.
- FDA Inspection 1166912 - 2022-03-15
- FDA Inspection 926691 - 2015-05-13
- FDA Inspection 808806 - 2012-11-20
- FDA Inspection 743223 - 2011-09-29
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