FDA Inspection
Arctic Biomaterials Oy (ABM)Arctic Biomaterials Oy (ABM) – FDA Inspection, Nov 17, 2022
Record Details
This FDA Inspection record concerns Arctic Biomaterials Oy (ABM), with an inspection on November 17, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Arctic Biomaterials Oy (ABM)
- Inspection Date
- November 17, 2022
- Product Type
- Devices
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ID · 9eb95a0c-07ea-42ec-9aec-f4498c5a6422
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1190793
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Arctic Biomaterials Oy (ABM)
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 5, 2025 | Not classified | Office of Inspections and Investigations |
Other documents for Arctic Biomaterials Oy (ABM)
- FDA Inspection 1276438 - 2025-06-05
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