FDA Inspection
Gureak NavarraGureak Navarra – FDA Inspection, Oct 20, 2016
Record Details
This FDA Inspection record concerns Gureak Navarra, with an inspection on October 20, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a7725ea1-6b31-410b-ae46-ce87c256bc51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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