FDA Inspection 828663 — Health Breakthroughs International LLC
The FDA completed an inspection of Health Breakthroughs International LLC on April 18, 2013 in Oregon City, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 18, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Oregon City, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1359 | 21 CFR 129.35(a)(3)(i) | Records - source water approval, sampling, analysis |
| 15493 | 21 CFR 111.25(b) | Procedures - calibrating automated, mechanical equip |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15578 | 21 CFR 111.155(c) | Components - quarantine |
| 15585 | 21 CFR 111.155(d)(2) | Components - unique identifier |
| 15762 | 21 CFR 111.205(a) | Master manufacturing record - each batch |
| 15825 | 21 CFR 111.65 | Quality control - quality, dietary supplement |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15853 | 21 CFR 111.73 | Specifications met - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |