FDA Inspection 897297 — Heron Botanicals, Inc.
The FDA completed an inspection of Heron Botanicals, Inc. on September 17, 2014 in Kingston, WA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Kingston, WA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |