FDA Inspection 1321344 — LXR Biotech
The FDA completed an inspection of LXR Biotech on Jun 10, 2026 in Rochester Hills, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 17 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 10, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 16017 | 21 CFR 111.140(b)(3) | Records - material review, disposition documentation |
| 18143 | 21 CFR 117.35(b)(1) | Cleaning and sanitizing substances - Safe and adequate |
| 18154 | 21 CFR 117.80(a)(2) | Appropriate quality control operations |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22862 | 21 CFR 111.105(i) | Quality control - required operations |
| 22868 | 21 CFR 111.140(b)(2) | Records - date and signature; review, approval, rejection |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |