FDA Inspection 925729 — KW Botanicals, Inc.
The FDA completed an inspection of KW Botanicals, Inc. on May 5, 2015 in San Anselmo, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 5, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- San Anselmo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15567 | 21 CFR 111.260(l)(4) | Batch record - approved, released, rejected |
| 15568 | 21 CFR 111.260(m) | Batch record - performance |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15648 | 21 CFR 111.465(a)(2) | Hold - reserve sample; closure system |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15669 | 21 CFR 111.310(c) | Laboratory facilities - dietary supplement specifications |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15954 | 21 CFR 111.113(a)(2) | Quality control master manufacturing record; material review, disposition |
| 15977 | 21 CFR 111.123(a)(1) | Quality control operations - master manufacturing record, modifications |