FDA Inspection 793932 — Ourvita DBA Ion Labs Inc.
The FDA completed an inspection of Ourvita DBA Ion Labs Inc. on August 2, 2012 in Largo, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 2, 2012
- Fiscal Year
- 2012
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Largo, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15560 | 21 CFR 111.260(k)(2) | Batch record - label |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15866 | 21 CFR 111.75(a)(2)(ii)(E) | Documentation - quality control, review, approve supplier |
| 15871 | 21 CFR 111.75(c)(2) | Specifications met - test, examinations; compliance |
| 15891 | 21 CFR 111.80(a) | Components packaging, labels received |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15908 | 21 CFR 111.90(b)(1) | Reprocessed, dietary supplement - no material review |
| 15955 | 21 CFR 111.113(a)(3) | Quality control - adulteration; material review, disposition |
| 16008 | 21 CFR 111.135 | Quality control operations - product complaints; investigate |