FDA Inspection
GENIAL DAY INCGENIAL DAY INC – FDA Inspection, Aug 3, 2021
Record Details
This FDA Inspection record concerns GENIAL DAY INC, with an inspection on August 3, 2021, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- GENIAL DAY INC
- Inspection Date
- August 3, 2021
- Product Type
- Devices
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ID · a7b12c37-f596-4ab9-8804-fca64dd43235
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1147768
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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