FDA Inspection 1028740 — Alxigna, Inc.
The FDA completed an inspection of Alxigna, Inc. on October 11, 2017 in Tracy, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 11, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Tracy, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16000 | 21 CFR 111.130 | Quality control operations - returned dietary supplement |