FDA Inspection 1179145 — RAPHA Health Network International, Inc.
The FDA completed an inspection of RAPHA Health Network International, Inc. on Sep 8, 2022 in Doral, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 8, 2022
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15403 | 21 CFR 111.12(b) | Personnel - quality control operations; responsibilities |
| 15526 | 21 CFR 111.30(c) | Equipment - automated - calibrate, inspect |
| 15531 | 21 CFR 111.255(a) | Batch record - every batch |
| 15534 | 21 CFR 111.255(c) | Batch record - each step |
| 15683 | 21 CFR 111.315(c) | Examination, testing methods; criteria for selecting |
| 15698 | 21 CFR 111.320(a) | Examination, testing; appropriate |
| 15702 | 21 CFR 111.320(b) | Examination, testing; scientifically valid |
| 15828 | 21 CFR 111.70(a) | Specifications - manufacturing process |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15966 | 21 CFR 111.117(a) | Quality control operations - calibrating processes |
| 15983 | 21 CFR 111.123(a)(7) | Quality control operations - finished batch, specifications |