FDA Inspection 1034091 — RAPHA Health Network International, Inc.
The FDA completed an inspection of RAPHA Health Network International, Inc. on Dec 4, 2017 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). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 4, 2017
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Doral, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15481 | 21 CFR 111.23(b) | Records - cleaning, pest control |
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15573 | 21 CFR 111.153 | Written procedures - product received; packaging, labeling |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15662 | 21 CFR 111.303 | Written procedures - laboratory operations |
| 15736 | 21 CFR 111.353 | Manufacturing operations - written procedures |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15760 | 21 CFR 111.205(b)(1) | Master manufacturing record-specifications; packaged, label |
| 15784 | 21 CFR 111.410(c) | Packaging, labels - master manufacturing record |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |