FDA Inspection 893912 — Paragon Vision Sciences, Inc.
The FDA completed an inspection of Paragon Vision Sciences, Inc. on Aug 20, 2014 in Mesa, AZ. 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
- Aug 20, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Mesa, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |