FDA Inspection 1229957 — LXR Biotech
The FDA completed an inspection of LXR Biotech on February 16, 2024 in Rochester Hills, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 16, 2024
- Fiscal Year
- 2024
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15542 | 21 CFR 111.260(b) | Batch record - date, time; maintenance |
| 15559 | 21 CFR 111.260(k)(1) | Batch record - identifier; labels |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15743 | 21 CFR 111.210(h)(3) | Master manufacturing record - specific actions; quality |
| 15744 | 21 CFR 111.210(h)(2) | Master manufacturing record - sampling, tests, examinations |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 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 |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |