El-Gen LLC FDA Inspection Record
El-Gen LLC is an FDA-inspected facility (FEI 3006432830) located in Bohemia, NY, US. RegDataLab tracks 7 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Apr 2, 2025: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (1 OAI, 5 VAI, 1 NAI)
- Last OAI inspection
- Jan 31, 2012
- Warning letters
- 1 listed by FDA for this FEI, latest Aug 3, 2012
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 2, 2025 | Voluntary Action Indicated (VAI) | Component - verify identity, dietary ingredient (21 CFR 111.75(a)(1)(i)) |
| Jul 15, 2022 | Voluntary Action Indicated (VAI) | Quality control - batch, product specifications (21 CFR 111.123(b)(2)) |
| Dec 17, 2018 | Voluntary Action Indicated (VAI) | Batch record - complete (21 CFR 111.255(b)) Dietary supplement containers - mix-ups (21 CFR 111.415(e)) Specifications identity, purity strength, composition (21 CFR 111.70(c)(2)) |
| Jan 13, 2016 | Voluntary Action Indicated (VAI) | Sampling plans; finished batches (21 CFR 111.315(b)(3)) |
| Feb 28, 2013 | Voluntary Action Indicated (VAI) | Manufacturing operations - written procedures (21 CFR 111.353) Record - product complaint; batch, lot, control number (21 CFR 111.570(b)(2)(ii)(B)) |
| Jan 31, 2012 | Official Action Indicated (OAI) | Batch record - complete (21 CFR 111.255(b)) Batch record - date, time; maintenance (21 CFR 111.260(c)) Batch record - component; identity, weight (21 CFR 111.260(e)) Components; add, verify (21 CFR 111.210(h)(3)(ii)(B)) and 6 more |
| Jan 31, 2012 | No Action Indicated (NAI) | No citations listed |
FDA record score
11 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
7 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Inspection classified VAI | Apr 2, 2025 | 6 x 1 | 6 |
| Inspection classified VAI | Jul 15, 2022 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Dec 17, 2018 | 6 x 0.25 | 1.5 |
| Inspection classified VAI | Jan 13, 2016 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Feb 28, 2013 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Aug 3, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jan 31, 2012 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- El-Gen LLC
- Location
- Bohemia, NY (US)
- Source
- inspections