# FDA 483 - Arctic Biomaterials Oy (ABM) - November 17, 2022

Source: https://www.keypedia.com/records/483/arctic-biomaterials-oy-abm/2b10143f-50fe-4c78-a35e-f77d3e9ac0c5

> FDA 483 for Arctic Biomaterials Oy (ABM) on November 17, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arctic Biomaterials Oy (ABM)
- Inspection Date: 2022-11-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Arctic Biomaterials Oy (ABM), a Class II device manufacturer in Tampere, Finland, was inspected by the FDA from November 15-17, 2022. The inspection revealed two significant observations related to inadequate quality system procedures. Specifically, the firm failed to adequately establish procedures for the disposition of nonconforming products and for management review meetings.

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Company: https://www.keypedia.com/companies/arctic-biomaterials-oy-abm/c416701b-23e8-4aba-906c-8f24f436754e

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd