FDA Inspection 1180911 — Summit Industries Inc.
The FDA completed an inspection of Summit Industries Inc. on Sep 30, 2022 in Niles, IL. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Niles, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 4437 | 21 CFR 803.40(b) | Report of malfunction likely to cause death or injury |