FDA Inspection 1309232 — Agupunt USA Corp
The FDA completed an inspection of Agupunt USA Corp on Mar 25, 2026 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 635 | 21 CFR 803.17(b)(1) | Info evaluated to determine if event was reportable |