FDA Inspection
Rising Eagle MedicalRising Eagle Medical – FDA Inspection, Oct 10, 2024
Record Details
This FDA Inspection record concerns Rising Eagle Medical, with an inspection on October 10, 2024, issued by the Denver District Office, covering medical devices & rad health.
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ID · aa4270a2-a83e-4c16-9a8b-bcb1b2b12b0a
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1251814
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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