FDA Inspection 832794 — Dr. Rath International, Inc.
The FDA completed an inspection of Dr. Rath International, Inc. on May 21, 2013 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). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15468 | 21 CFR 111.20(c)(2) | Physical plant - material review and disposition |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15819 | 21 CFR 111.55 | Production, process controls - implement |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15855 | 21 CFR 111.73 | Specifications met - received product identified |
| 15989 | 21 CFR 111.127 | Quality control operations - packaging, labeling |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |