FDA Inspection 1301800 — Highland Laboratories Inc
The FDA completed an inspection of Highland Laboratories Inc on Feb 6, 2026 in Mount Angel, OR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 20 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- Feb 6, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Mount Angel, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15723 | 21 CFR 111.365(i) | Metal, foreign material |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |
| 15972 | 21 CFR 111.120(b) | Quality control operations - specifications; components, packaging, labels |
| 15980 | 21 CFR 111.123(a)(4) | Quality control operations - material review, disposition decision |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |
| 22818 | 21 CFR 111.10(b) | Hygienic practices |
| 22819 | 21 CFR 111.12 | Personnel - qualifications |
| 22823 | 21 CFR 111.15(b) | Physical plant - clean and sanitary |
| 22831 | 21 CFR 111.20(d) | Physical plant - construction |
| 22836 | 21 CFR 111.27(a) | Equipment - design - appropriate and suitable |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |