FDA Inspection 821443 — Professional Botanicals, Inc.
The FDA completed an inspection of Professional Botanicals, Inc. on Feb 27, 2013 in Ogden, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 27, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Ogden, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16040 | 21 CFR 111.610(a) | Records - available; FDA |