FDA Inspection 675465 — Biowave Corporation
The FDA completed an inspection of Biowave Corporation on Jul 28, 2010 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 28, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Westport, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |