FDA Inspection 576051 — NovoSci Corporation
The FDA completed an inspection of NovoSci Corporation on Apr 7, 2009 in Conroe, TX. 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
- Apr 7, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Conroe, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3288 | 21 CFR 820.90(b)(1) | Documentation of disposition, justification, signature |
| 3369 | 21 CFR 820.198(a)(1) | Uniform and timely processing |
| 3433 | 21 CFR 820.75(c) | Process changes - review, evaluation and revalidation |
| 3696 | 21 CFR 820.100(b) | Documentation |