FDA Inspection 983503 — Norax Supplements LLC
The FDA completed an inspection of Norax Supplements LLC on August 26, 2016 in Cedartown, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 26, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Cedartown, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15425 | 21 CFR 111.15(i) | Hand-washing facilities |
| 15432 | 21 CFR 111.15(e)(2) | Water supply - may be component - suitability |
| 15480 | 21 CFR 111.20(h) | Physical plant - screening against pests |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 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 |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |