FDA Inspection
ADVIHAIR SpAADVIHAIR SpA – FDA Inspection, Dec 7, 2023
Record Details
This FDA Inspection record concerns ADVIHAIR SpA, with an inspection on December 7, 2023, issued by the Office of Inspections and Investigations.
- Company
- ADVIHAIR SpA
- Inspection Date
- December 7, 2023
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ID · ccf11d9e-bde6-475c-ae3e-2ab3c43852d8
Inspection Facts
- Inspection number
- 1224600
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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