FDA Inspection 858943 — Wishgarden Herbs, Inc.
The FDA completed an inspection of Wishgarden Herbs, Inc. on December 20, 2013 in Louisville, CO. 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
- December 20, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Louisville, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15970 | 21 CFR 111.120 | Quality control operations - components, packaging, labels |
| 16013 | 21 CFR 111.140(b)(1) | Records - quality control operations; responsibilities |
| 16056 | 21 CFR 111.535(a) | Records - returned dietary supplement: readily available |