FDA Inspection
EIFFAGE Energie Systemes ElectroniqueEIFFAGE Energie Systemes Electronique – FDA Inspection, Sep 16, 2025
Record Details
This FDA Inspection record concerns EIFFAGE Energie Systemes Electronique, with an inspection on September 16, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Inspection Date
- September 16, 2025
- Product Type
- Medical Devices & Rad Health
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ID · 2d76c680-a222-4c14-ad53-ee0d34af4af6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1286530
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.75(c)Process changes - review, evaluation and revalidation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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