FDA Inspection 1144206 — Alurent Products Inc
The FDA completed an inspection of Alurent Products Inc on June 18, 2021 in Cameron Park, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 18, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Cameron Park, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15431 | 21 CFR 111.15(e)(1) | Water supply - not component - suitability |
| 15443 | 21 CFR 111.15(b)(2) | Physical plant - repair |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15547 | 21 CFR 111.260(g) | Batch record - results; monitoring |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 16495 | FDCA 601(c) | Insanitary conditions; injurious to health |