FDA Inspection 877752 — Summit Beverage Group, LLC
The FDA completed an inspection of Summit Beverage Group, LLC on May 7, 2014 in Marion, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 7, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Marion, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 9986 | 21 CFR 120.24(c) | Process controls - not exempt, single facility |