FDA Inspection 846353 — Big Red, Inc
The FDA completed an inspection of Big Red, Inc on August 23, 2013 in Waco, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 23, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Waco, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1422 | 21 CFR 110.20(b)(4) | Floors, walls and ceilings |
| 15402 | 21 CFR 111.12 | Personnel - quality control personnel - qualified |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |