FDA Inspection 1337268 — Primo Passi
The FDA completed an inspection of Primo Passi on Sep 23, 2026 in Orlando, 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
- Sep 23, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Orlando, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23022 | ISO 13485:2016 Clause 4.1.4 | QMS processes not adequately managed |
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |