FDA Inspection 1268397 — Western Innovations, Inc.
The FDA completed an inspection of Western Innovations, Inc. on April 30, 2025 in Denver, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 26 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Denver, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15518 | 21 CFR 111.27(d)(4) | Contact surfaces - not in direct contact - cleaning |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15771 | 21 CFR 111.415(h) | Obsolete labels, packaging - dispose |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15866 | 21 CFR 111.75(a)(2)(ii)(E) | Documentation - quality control, review, approve supplier |
| 15870 | 21 CFR 111.75(c)(1) | Specifications met - verify; production, process control |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15933 | 21 CFR 111.105(b) | Quality control - supplier qualification |
| 22809 | 21 CFR 111.353 | Written procedures - establish; manufacturing operations |
| 22834 | 21 CFR 111.25 | Equipment - establish written procedures |
| 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 |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22872 | 21 CFR 111.155(e) | Components - contamination, deterioration, mix-ups |
| 22882 | 21 CFR 111.180(b) | Documentation - components |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22886 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications, quality; packaging, labeling |
| 22888 | 21 CFR 111.210 | Master manufacturing record - record requirements |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22891 | 21 CFR 111.303 | Written procedures - establish; laboratory |
| 22897 | 21 CFR 111.325(b) | Make and keep records - laboratory operations |
| 22900 | 21 CFR 111.403 | Written procedures - establish; packaging & labeling |
| 22916 | 21 CFR 111.570(b)(2)(ii) | Record - product complaint; written record information |