FDA Inspection 942354 — Project CU Challenge Unlimited
The FDA completed an inspection of Project CU Challenge Unlimited on Sep 3, 2015 in Saint Louis, MO. 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). 5 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1801 | 21 CFR 211.84(a) | Components withheld from use pending release |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4372 | 21 CFR 211.188(b)(8) | Labeling control records including specimens or copies |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |