FDA Inspection 944174 — Raphah, Inc.
The FDA completed an inspection of Raphah, Inc. on September 30, 2015 in New Brunswick, NJ. 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
- September 30, 2015
- Fiscal Year
- 2015
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- New Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15491 | 21 CFR 111.25 | Equipment - procedures |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15645 | 21 CFR 111.455(c) | Hold - mix-up, contamination, deterioration |
| 15652 | 21 CFR 111.465(b) | Retain reserve samples - 1 year, 2 years |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15893 | 21 CFR 111.80(c) | Specifications - representative samples; finished batch |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 15930 | 21 CFR 111.105 | Quality control - ensure quality; package, labeled, master record |