FDA Inspection 852344 — Health Value Inc.
The FDA completed an inspection of Health Value Inc. on October 10, 2013 in Hauppauge, NY. 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
- October 10, 2013
- Fiscal Year
- 2014
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Hauppauge, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 16071 | 21 CFR 111.35(b)(3) | Documentation - instruments, controls; calibrations |