FDA Inspection 926579 — Summit Beverage Group, LLC
The FDA completed an inspection of Summit Beverage Group, LLC on May 15, 2015 in Marion, VA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 15, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Marion, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 15549 | 21 CFR 111.260(i) | Batch record - specifications |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15982 | 21 CFR 111.123(a)(6) | Quality control operations - in-process specifications |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 4464 | 21 CFR 108.25(c)(1) | Registration |
| 9919 | 21 CFR 120.10(a) | Corrective action - predetermined plan inadequate |
| 9936 | 21 CFR 120.7(a) | Hazard analysis - written - elements |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |