FDA Inspection
EuropTec Polymer AGEuropTec Polymer AG – FDA Inspection, Sep 25, 2025
Record Details
This FDA Inspection record concerns EuropTec Polymer AG, with an inspection on September 25, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · a56e2931-33f7-468e-9d15-b9053a3ee52e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1285196
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.186QSR
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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