FDA Inspection 1144650 — Custom Nutraceuticals, LLC
The FDA completed an inspection of Custom Nutraceuticals, LLC on June 23, 2021 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 23, 2021
- Fiscal Year
- 2021
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15641 | 21 CFR 111.453 | Written procedures - holding |
| 15660 | 21 CFR 111.475(b)(2) | Records - product distribution |
| 15681 | 21 CFR 111.315(d) | Standard reference materials; criteria for selecting |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 15869 | 21 CFR 111.75(c) | Specifications met - verify; finished batch |
| 15978 | 21 CFR 111.123(a)(2) | Quality control operations - batch production records |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |