1018703
RXW CGMP, LLC — FEI 3006490916
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Dearborn, MI (United States)
Citations
| ID | CFR | Description |
|---|
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15544 | 21 CFR 111.260(d) | Batch record - component; unique identifier |
| 15546 | 21 CFR 111.260(f) | Batch record - yield |
| 15551 | 21 CFR 111.260(j)(1) | Batch record - date, each step |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15623 | 21 CFR 111.180(b)(2) | Records - receiving; components, packaging, labels, products |
| 15625 | 21 CFR 111.180(b)(3) | Documentation - components |
| 15737 | 21 CFR 111.210(h)(5) | Corrective action plans |
| 15739 | 21 CFR 111.210(h)(3)(ii)(B) | Components; add, verify |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 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 |
| 15885 | 21 CFR 111.77(a) | Specifications not met - reject, quality control |
| 15903 | 21 CFR 111.87 | Material review, disposition - quality control |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |