FDA Inspection 1113587 — Autumn Harp, Inc.
The FDA completed an inspection of Autumn Harp, Inc. on December 19, 2019 in Essex Junction, VT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 19, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Essex Junction, VT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |