FDA Inspection 894759 — Better Health Lab, Inc
The FDA completed an inspection of Better Health Lab, Inc on September 22, 2014 in Hackensack, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2014
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hackensack, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15400 | 21 CFR 111.12(a) | Personnel - qualified - general |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |