FDA Inspection 790628 — Quantum Herbal Products
The FDA completed an inspection of Quantum Herbal Products on Jun 28, 2012 in Saugerties, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 28, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Saugerties, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15351 | FDCA 761(b)(1) | No AE report made (dietary supplement) |
| 15779 | 21 CFR 111.415(a) | Clean, sanitize - filling, packaging equipment |
| 15800 | 21 CFR 111.560(a)(2) | Product complaint - quality control investigate |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15860 | 21 CFR 111.75(a)(2) | Component - confirm identity; specifications met |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 16047 | 21 CFR 111.510 | Returned dietary supplement - material review, disposition |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |