FDA Inspection
Miami Fat Supply, IncMiami Fat Supply, Inc – FDA Inspection, May 15, 2026
Record Details
This FDA Inspection record concerns Miami Fat Supply, Inc, with an inspection on May 15, 2026, issued by the Florida District Office, covering medical devices & rad health.
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ID · f7d98d8a-d3ba-46be-aef5-833652944530
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1318314
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.1.3QMS process records not established or maintained
- ISO 13485:2016 Clause 7.3.9Requirements for design and development changes not met before implementation
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
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Other FDA inspections of Miami Fat Supply, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 14, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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