FDA Inspection 976742 — Sales USA, Inc
The FDA completed an inspection of Sales USA, Inc on July 7, 2016 in Gladewater, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 7, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Gladewater, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12742 | 21 CFR 120.8(a) | HACCP plan not implemented |
| 12745 | 21 CFR 120.8(b)(1) | HACCP plan - food hazards not listed |
| 12747 | 21 CFR 120.8(b)(3) | HACCP plan - critical limits not listed or not adequate |
| 1554 | 21 CFR 110.35(a) | Cleaning and sanitizing operations |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |
| 9936 | 21 CFR 120.7(a) | Hazard analysis - written - elements |
| 9947 | 21 CFR 120.11(b) | HACCP plan - not validated |
| 9955 | 21 CFR 120.11(a)(1) | Verification activities - minimum |
| 9961 | 21 CFR 120.24(a) | Process controls - HACCP plan - 5 log reduction |