FDA Inspection
AFP ManufacturingAFP Manufacturing – FDA Inspection, Jun 27, 2019
Record Details
This FDA Inspection record concerns AFP Manufacturing, with an inspection on June 27, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 444d5260-fcd2-4fe5-8660-df7741562585
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1094365
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
11- 21 CFR 820.100(b)Documentation
- 21 CFR 820.184DHR content
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of AFP Manufacturing
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2024 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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