FDA Inspection 1195390 — Alaron Products Limited
The FDA completed an inspection of Alaron Products Limited on January 12, 2023 in Nelson. 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
- January 12, 2023
- Fiscal Year
- 2023
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Nelson (New Zealand)
Citations
| ID | CFR | Description |
|---|---|---|
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 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 |
| 15902 | 21 CFR 111.83(b)(4) | Reserve sample - twice the quantity |