981915
Absonutrix, LLC — FEI 3012107499
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 5, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Greensboro, NC (United States)
Citations
| ID | CFR | Description |
|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |