1053753
LXR Biotech — FEI 3010744574
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 23, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Rochester Hills, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15563 | 21 CFR 111.260(l)(1)(i) | Batch record - quality control review; monitoring |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15863 | 21 CFR 111.75(a)(2)(ii)(B) | Component - certificate of analysis |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15901 | 21 CFR 111.83(b)(3) | Reserve sample - retained |