FDA Inspection 1069216 — Prosec Protection Systems, Inc.
The FDA completed an inspection of Prosec Protection Systems, Inc. on October 12, 2018 in New Brunswick, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 12, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |