FDA Inspection
Biomerics AlajuelaBiomerics Alajuela – FDA Inspection, May 5, 2023
Record Details
This FDA Inspection record concerns Biomerics Alajuela, with an inspection on May 5, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 38302bfa-32aa-4fc9-9620-bc68056d1415
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206089
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
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Other FDA inspections of Biomerics Alajuela
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 8, 2019 | Not classified | Office of Inspections and Investigations | |
| November 13, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biomerics Alajuela
- FDA Inspection 1107122 - 2019-08-08
- FDA Inspection 857109 - 2013-11-13
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