FDA Inspection 1266778 — Hearthy Foods, Inc.
The FDA completed an inspection of Hearthy Foods, Inc. on April 14, 2025 in Los Angeles, CA. 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
- April 14, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15434 | 21 CFR 111.15(d)(2) | Pest control measures |
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15734 | 21 CFR 111.360 | Manufacturing operations - sanitation |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 18141 | 21 CFR 117.35(a) | Sanitary operations - Plant maintenance |
| 18147 | 21 CFR 117.35(e) | Sanitation of non-food-contact surfaces - Manner and frequency |
| 22701 | 21 CFR 117.130(a)(1) | Hazard analysis - Conducted |
| 22809 | 21 CFR 111.353 | Written procedures - establish; manufacturing operations |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22813 | 21 CFR 111.553 | Written procedures - establish; product complaint |
| 22815 | 21 CFR 111.8 | Written procedures - establish; personnel |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |