FDA Inspection 1263061 — Harmonic Energetic Technologies Inc.
The FDA completed an inspection of Harmonic Energetic Technologies Inc. on Mar 7, 2025 in Liverpool, NY. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 7, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Liverpool, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |