FDA Inspection 807814 — Herbalist and Alchemist, Inc.
The FDA completed an inspection of Herbalist and Alchemist, Inc. on November 16, 2012 in Washington, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 16, 2012
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Washington, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15382 | 21 CFR 111.8 | Written procedures - personnel qualifications |
| 15496 | 21 CFR 111.27(b) | Instruments - calibration |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |