FDA Inspection 1268191 — Garry N Sun USA,Inc.
The FDA completed an inspection of Garry N Sun USA,Inc. on April 25, 2025 in Reno, NV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Reno, NV (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15843 | 21 CFR 111.70(g) | Specifications - finished packaging, labeling |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |