FDA Inspection 1318314 — Miami Fat Supply, Inc
The FDA completed an inspection of Miami Fat Supply, Inc on May 15, 2026 in Fruitland Park, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fruitland Park, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23021 | ISO 13485:2016 Clause 4.1.3 | QMS process records not established or maintained |
| 23133 | ISO 13485:2016 Clause 7.3.9 | Requirements for design and development changes not met before implementation |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |