FDA Inspection 839955 — Mira Health Products Ltd.
The FDA completed an inspection of Mira Health Products Ltd. on July 17, 2013 in Farmingdale, NY. 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
- July 17, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15524 | 21 CFR 111.30(a) | Equipment - automated - design, selection |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 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 |
| 15867 | 21 CFR 111.75(b)(1) | Specifications met, in-process - quality finished batch |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15903 | 21 CFR 111.87 | Material review, disposition - quality control |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |