FDA Inspection
DeGood Dimensional Concepts, IncDeGood Dimensional Concepts, Inc – FDA Inspection, Feb 7, 2019
Record Details
This FDA Inspection record concerns DeGood Dimensional Concepts, Inc, with an inspection on February 7, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 1f56d90a-ed3f-46c2-8dfe-7b5d2e12f0bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1079430
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.198(e)Maintained
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.184DHR content
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