FDA Inspection
Adeor Medical AGAdeor Medical AG – FDA Inspection, Sep 18, 2019
Record Details
This FDA Inspection record concerns Adeor Medical AG, with an inspection on September 18, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · f87994b7-7010-4170-8130-1c3225e3d2f8
Inspection Facts
- Inspection number
- 1102256
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.30(d)Design output - documentation
- 21 CFR 820.30(e)Design review - documentation
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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