FDA Inspection 1083564 — Absonutrix, LLC
The FDA completed an inspection of Absonutrix, LLC on March 22, 2019 in Greensboro, NC. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 22, 2019
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Greensboro, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15388 | 21 CFR 111.10(b) | Personnel - hygienic practices |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |