FDA Inspection 1155039 — Schreiber Foods, Inc.
The FDA completed an inspection of Schreiber Foods, Inc. on October 14, 2021 in Beloit, WI. 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
- October 14, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Beloit, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1040 | 21 CFR 113.10 | Operators |
| 1483 | 21 CFR 113.87(a) | Operating processes not posted |
| 16288 | 21 CFR 113.100(b) | Review of processing and production records |
| 16461 | 21 CFR 113.40(g)(1)(i)(B)(1) | Aseptic processing: recorder, appropriate chart |
| 16480 | 21 CFR 113.40(g)(1)(ii)(E) | Aseptic processing: steam seals performance, records, freq |
| 18159 | 21 CFR 117.80(b)(6) | Raw materials - Thawing |
| 19030 | 21 CFR 117.130(a)(1) | Hazard Analysis - Identification of Hazard |
| 19036 | 21 CFR 117.145(a) | Process Controls Monitoring Procedures: Establish Implement |
| 2848 | 21 CFR 113.40(g)(1)(i)(B)(3) | Adjusted to agree with TID |
| 2886 | 21 CFR 113.40(i) | Thermal process crit factors-measurement adequate & accurate |
| 2899 | 21 CFR 113.40(g)(2)(ii)(C) | Operating conditions - observed, recorded |
| 4181 | 21 CFR 113.89 | Process deviation identification |
| 4529 | 21 CFR 108.35(c)(2)(ii) | Process change reporting to CFSAN |