FDA Inspection 1030356 — Summit Beverage Group, LLC
The FDA completed an inspection of Summit Beverage Group, LLC on March 3, 2017 in Marion, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 3, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Marion, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15671 | 21 CFR 111.315 | Laboratory control processes - requirements |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3086 | 21 CFR 114.100(b) | Maintenance of processing and production records |
| 4470 | 21 CFR 108.25(c)(2) | Process filing |
| 4475 | 21 CFR 108.25(c)(3)(i) | Process adherence |