FDA Inspection 1229053 — Dr. Rath International, Inc.
The FDA completed an inspection of Dr. Rath International, Inc. on March 26, 2026 in San Jose, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2026
- Fiscal Year
- 2026
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15785 | 21 CFR 111.410(b) | Label, packaging - discrepancies |
| 22811 | 21 CFR 111.453 | Written procedures - establish; holding and distribution |
| 22814 | 21 CFR 111.553 | Written procedures - follow; product complaint |
| 22819 | 21 CFR 111.12 | Personnel - qualifications |
| 22859 | 21 CFR 111.103 | Written procedures - establish; quality control operations |
| 22883 | 21 CFR 111.180(b)(3) | Documentation - requirements |
| 22903 | 21 CFR 111.415(f) | Batch, lot, control number |
| 22913 | 21 CFR 111.560(c) | Product complaint - review, investigation |