FDA Inspection 546595 — Summit Industries Inc.
The FDA completed an inspection of Summit Industries Inc. on Nov 10, 2008 in Niles, IL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Nov 10, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2279 | 21 CFR 820.20(b)(2) | Resources |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3667 | 21 CFR 820.20(c) | Management review accomplishment |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3671 | 21 CFR 820.25(a) | Personnel |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 540 | 21 CFR 820.70(b) | Production and process changes - failure to follow procedure |