FDA Inspection 1288042 — FreshRealm, Inc
The FDA completed an inspection of FreshRealm, Inc on October 22, 2025 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 22, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Indianapolis, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18140 | 21 CFR 117.20(b) | Plant construction and design |
| 18153 | 21 CFR 117.80(a) | Plant operations - Precautions |
| 22714 | 21 CFR 117.410(c) | Supply-chain program - Assurance (Adequate) |
| 22717 | 21 CFR 117.130(a)(1) | Hazard analysis - Identification of hazard |
| 906 | 21 CFR 123.6(b) | HACCP plan location |
| 918 | 21 CFR 123.8(a) | Verification - reviewers qualifications |
| 960 | 21 CFR 123.6(c)(2) | Critical control points |