FDA Inspection 1273108 — Nutratech LLC
The FDA completed an inspection of Nutratech LLC on October 15, 2025 in Phoenix, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 21 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 15, 2025
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Phoenix, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15433 | 21 CFR 111.15(d)(1) | Animals and pests in facility |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |
| 22814 | 21 CFR 111.553 | Written procedures - follow; product complaint |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22823 | 21 CFR 111.15(b) | Physical plant - clean and sanitary |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22840 | 21 CFR 111.35(b) | Make and keep records - equipment and utensils |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |