FDA Inspection 790491 — Challenge Unlimited, Inc.
The FDA completed an inspection of Challenge Unlimited, Inc. on Jul 12, 2012 in Alton, 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). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 12, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alton, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3309 | 21 CFR 820.120(b) | Examination for accuracy |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 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 |