FDA Inspection 1247458 — Percussionaire Corporation
The FDA completed an inspection of Percussionaire Corporation on Aug 22, 2024 in Sandpoint, ID. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 22, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sandpoint, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21426 | 21 CFR 820.198(e) | Records of complaint investigation - UDI |
| 21427 | 21 CFR 820.200(d) | Service reports - UDI |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |