FDA Inspection 1319378 — Biowave Corporation
The FDA completed an inspection of Biowave Corporation on May 26, 2026 in Westport, CT. 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
- May 26, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Westport, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23067 | ISO 13485:2016 Clause 6.1(a) | Resources for quality management system have not been determined or provided |
| 23150 | ISO 13485:2016 Clause 7.4.3 | Purchased product verification activities not established or implemented |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |