FDA Inspection
Byron Medical, IncByron Medical, Inc – FDA Inspection, Sep 11, 2009
Record Details
This FDA Inspection record concerns Byron Medical, Inc, with an inspection on September 11, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Byron Medical, Inc
- Inspection Date
- September 11, 2009
- Product Type
- Devices
View Company Profile
ID · a98be176-9ac3-4557-a711-d5467c21e661
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 612366
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.18(e)MDR not evaluated per 820.198
- 21 CFR 820.100(b)Documentation
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