FDA Inspection
D-Eye srlD-Eye srl – FDA Inspection, Oct 11, 2018
Record Details
This FDA Inspection record concerns D-Eye srl, with an inspection on October 11, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e76467da-ebcf-4880-8d7a-d87a4a3830aa
Inspection Facts
- Inspection number
- 1070168
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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