FDA Inspection 1074665 — El-Gen LLC
The FDA completed an inspection of El-Gen LLC on Dec 17, 2018 in Bohemia, NY. 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). 3 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 17, 2018
- Fiscal Year
- 2019
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Bohemia, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15775 | 21 CFR 111.415(e) | Dietary supplement containers - mix-ups |
| 15834 | 21 CFR 111.70(c)(2) | Specifications identity, purity strength, composition |