FDA Inspection 962509 — C-Axis PR., Inc.
The FDA completed an inspection of C-Axis PR., Inc. on Feb 19, 2016 in Caguas, PR. 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
- Feb 19, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Caguas, PR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |