FDA Inspection 833514 — Health & Beyond, LLC
The FDA completed an inspection of Health & Beyond, LLC on May 30, 2013 in Pompano Beach, FL. 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
- May 30, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Pompano Beach, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15733 | 21 CFR 111.365 | Manufacturing operations - prevent contamination |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15921 | 21 CFR 111.95(b)(2) | Documentation - supplier qualification |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |