FDA Inspection
AFP ManufacturingAFP Manufacturing – FDA Inspection, May 31, 2024
Record Details
This FDA Inspection record concerns AFP Manufacturing, with an inspection on May 31, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9ec22951-c049-4260-a0aa-0e2f1ec5e1e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1240105
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of AFP Manufacturing
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 27, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for AFP Manufacturing
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