FDA Inspection 988266 — Professional Botanicals, Inc.
The FDA completed an inspection of Professional Botanicals, Inc. on Oct 11, 2016 in Ogden, UT. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 11, 2016
- Fiscal Year
- 2017
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15411 | 21 CFR 111.14(b)(2) | Personnel - records - training date, type, persons |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15845 | 21 CFR 111.73 | Specifications met - quality |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |