FDA Inspection 907599 — FSS, Inc.
The FDA completed an inspection of FSS, Inc. on January 9, 2015 in Red Wing, MN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 19 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 9, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Red Wing, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1173 | 21 CFR 110.40(f) | Q.C. instrument accuracy, maintenance |
| 1316 | 21 CFR 113.87(c) | Initial temperature of container contents |
| 1487 | 21 CFR 113.87(b) | Visual indicators not used |
| 1556 | 21 CFR 110.35(b)(2) | Storage requirements |
| 1560 | 21 CFR 110.35(c) | Lack of effective pest exclusion |
| 1689 | 21 CFR 110.80 | Reasonable precautions |
| 2386 | 21 CFR 110.80(a)(1) | Storage |
| 2392 | 21 CFR 110.80(b)(1) | Maintenance of equip., utensils, and finished food packaging |
| 2513 | 21 CFR 113.40(e)(9) | Critical Factors measured, recorded |
| 3071 | 21 CFR 114.80(a)(1) | Scheduled process |
| 3072 | 21 CFR 114.80(a)(1) | Thermal processing |
| 3078 | 21 CFR 114.80(b) | Code - required elements |
| 3080 | 21 CFR 114.83 | Scheduled process establishment |
| 3643 | 21 CFR 110.10(b)(5) | Glove condition |
| 3658 | 21 CFR 110.37(e)(2) | Hand cleaning and sanitizing preparations |
| 3659 | 21 CFR 110.37(e)(3) | Hand drying |
| 3826 | 21 CFR 113.40(e)(1)(ii) | TID record of accuracy |
| 3871 | 21 CFR 113.60(a)(2) | Record of cold water vacuum check |
| 4519 | 21 CFR 108.35(c)(3)(i) | Process adherence |