FDA Inspection 1179982 — Pulmone Advanced Medical Devices, Ltd.
The FDA completed an inspection of Pulmone Advanced Medical Devices, Ltd. on Sep 22, 2022 in Ra'Anana. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 22, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ra'Anana (Israel)
Citations
| ID | CFR | Description |
|---|---|---|
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |