FDA Inspection 1043912 — Unique Encapsulation Technology, LLC
The FDA completed an inspection of Unique Encapsulation Technology, LLC on March 9, 2018 in Landing, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 9, 2018
- Fiscal Year
- 2018
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Landing, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15706 | 21 CFR 111.325(a) | Laboratory operations: electronic |
| 15710 | 21 CFR 111.325(b)(2)(i) | Document; laboratory methodology followed |
| 15817 | 21 CFR 111.570(b)(2)(ii)(F) | Record - product complaint; findings |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |