FDA Inspection
Miami Fat Supply, IncMiami Fat Supply, Inc – FDA Inspection, Oct 14, 2015
Record Details
This FDA Inspection record concerns Miami Fat Supply, Inc, with an inspection on October 14, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Miami Fat Supply, Inc
- Inspection Date
- October 14, 2015
- Product Type
- Devices
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ID · ef0d1fa3-fe55-4580-8de4-50f857a3d573
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 945549
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Miami Fat Supply, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | VAI | Florida District Office | Compliance: Devices |
| July 21, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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