FDA Inspection 1115979 — Custom Nutraceuticals, LLC
The FDA completed an inspection of Custom Nutraceuticals, LLC on Jan 23, 2020 in Commack, NY. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 23, 2020
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Foodborne Biological Hazards
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15453 | 21 CFR 111.16 | Written procedures - cleaning |
| 15763 | 21 CFR 111.205(a) | Master manufacturing record - unique formulation |
| 15786 | 21 CFR 111.410(b) | Labels - issuance, use |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15953 | 21 CFR 111.113(a)(1) | Quality control production, process control; material review, disposition |