FDA Inspection 833265 — PrutectRx
The FDA completed an inspection of PrutectRx on May 24, 2013 in Englewood, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 24, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Englewood, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15845 | 21 CFR 111.73 | Specifications met - quality |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |