FDA Inspection
Model SolutionModel Solution – FDA Inspection, Aug 22, 2024
Record Details
This FDA Inspection record concerns Model Solution, with an inspection on August 22, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 984e8fa9-8160-4555-bd16-eb18928f9aa5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1247573
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.250(b)Sampling plans
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