FDA Inspection 826434 — Health One Pharmaceuticals Inc
The FDA completed an inspection of Health One Pharmaceuticals Inc on May 7, 2013 in City Of Industry, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 20 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 7, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- City Of Industry, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15442 | 21 CFR 111.15(b)(1) | Physical plant - clean and sanitary |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15523 | 21 CFR 111.27(d)(7) | Utensils - store |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15570 | 21 CFR 111.153 | Written procedures - components |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15840 | 21 CFR 111.70(e) | Specifications - contamination limits |
| 15850 | 21 CFR 111.73 | Specifications met in-process purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15862 | 21 CFR 111.75(a)(2) | Appropriate tests, examinations; certificate of analysis |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15872 | 21 CFR 111.75(c)(3) | Specifications met identity,purity, strength, comp,; basis |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15944 | 21 CFR 111.105(i) | QC - required operations master manufacturing/batch records |
| 15945 | 21 CFR 111.105(i) | QC - required operations packaging/labeling operations |