FDA Inspection 985960 — The Shake Guy LLC
The FDA completed an inspection of The Shake Guy LLC on Sep 7, 2016 in Ozark, 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). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 7, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Ozark, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1427 | 21 CFR 110.20(b)(5) | Safety lighting and glass |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15648 | 21 CFR 111.465(a)(2) | Hold - reserve sample; closure system |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15791 | 21 CFR 111.403 | Written procedures -packaging operations |
| 15826 | 21 CFR 111.65 | Quality control - packaged, labeled |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |