FDA Inspection 1314952 — PureWave Life LLC
The FDA completed an inspection of PureWave Life LLC on Apr 29, 2026 in Boynton Beach, 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 29, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Boynton Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23026 | ISO 13485:2016 Clause 4.1.5 | External party controls do not include written quality agreements |
| 23060 | ISO 13485:2016 Clause 5.6.1 | Management review procedures not documented |
| 23101 | ISO 13485:2016 Clause 7.3.2 | Design and development planning documentation not adequate |
| 23221 | ISO 13485:2016 Clause 8.2.4 | Internal audit procedures not documented |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |