FDA Inspection 793404 — Phoenix Instruments Inc.
The FDA completed an inspection of Phoenix Instruments Inc. on August 1, 2012 in Lisle, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 1, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Lisle, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |