Company
FinlandArctic Biomaterials Oy (ABM), Tampere, Finland – FDA Inspections
Inspection records and compliance data for Arctic Biomaterials Oy (ABM) in Tampere. 2 FDA inspections on record, last inspected June 05, 2025.
Company Profile
This profile covers Arctic Biomaterials Oy (ABM) based in Tampere, Finland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 17, 2022. Last inspected June 5, 2025.
Most cited issue areas
- Management review - Lack of or inadequate procedures1 inspection
- Procedures for product review,disposition lack of/inadequate1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2025 | Not classified | Medical Devices & Rad Health | 1276438 |
| November 17, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1190793 |
FDA documents
Form 483s (1)
People (1)
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Company Information
Name
Arctic Biomaterials Oy (ABM)
FEI Number
3015780293
Address
Region Of Tampere, Arvo Ylpon Katu 41, Tampere, Finland
Country
Finland
ID: c416701b-23e8-4aba-906c-8f24f436754e