FDA Inspection 1263581 — LXR Biotech
The FDA completed an inspection of LXR Biotech on Mar 12, 2025 in Rochester Hills, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Mar 12, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15583 | 21 CFR 111.155(d)(1) | Components - identify lot received |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 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 |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15886 | 21 CFR 111.77(b) | Specifications not met - identity; component, reject |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15975 | 21 CFR 111.120(e) | Quality control operations - quarantine |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |
| 22908 | 21 CFR 111.503 | Written procedures - establish; returned dietary supplements |