FDA Inspection 1149488 — Good Health Manufacturing
The FDA completed an inspection of Good Health Manufacturing on August 20, 2021 in Chandler, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 20, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Chandler, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15389 | 21 CFR 111.10(b)(1) | Outer garments |
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15521 | 21 CFR 111.27(d)(6) | Cleaning compounds - adequate, safe |
| 15525 | 21 CFR 111.30(b) | Equipment - automated - suitability |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15642 | 21 CFR 111.455(a) | Hold - temperature, humidity, light |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15732 | 21 CFR 111.365(a) | Conditions, controls -protect; microorganisms, contamination |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |