FDA Inspection 1017603 — Wells Enterprises, Inc.
The FDA completed an inspection of Wells Enterprises, Inc. on July 12, 2017 in Dunkirk, NY. 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
- July 12, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dunkirk, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18139 | 21 CFR 117.20(a) | Grounds |
| 18141 | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance |
| 18144 | 21 CFR 117.35(b)(2) | Toxic chemicals - Identified, held, stored |
| 18149 | 21 CFR 117.40 | Equipment and utensils - Design and maintenance |
| 18161 | 21 CFR 117.80(c) | Manufacturing, processing, packing, holding - Controls |
| 19059 | 21 CFR 117.145(a) | Sanitation Controls Monitoring Proced: Establish Implement |
| 19062 | 21 CFR 117.150(a)(1) | Sanitation Controls Corrective Action Proced: Estab Implemnt |
| 19066 | 21 CFR 117.165(b) | Sanitation Controls Verif Procedures: Establish Implement |