GUERBET LLC
FDA Regulatory Profile
GUERBET LLC has 2 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0138-2020 · Class III · Sep 13, 2019
- Latest inspection
- Aug 28, 2025 · VAI
Reviewing GUERBET LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.
Check this supplier
Or check GUERBET LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.
Get a free API key
Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 2 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 5 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0138-2020 | Class III | Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefilled Syringe For Power… | Sep 13, 2019 |
| D-0137-2020 | Class II | Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, packaged in 1 - 100 mL… | Sep 13, 2019 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Aug 28, 2025 | Princeton, NJ | Drugs | Voluntary Action Indicated (VAI) | 3014243475 |
| Apr 26, 2024 | Lanester, France | Drugs | Voluntary Action Indicated (VAI) | 3002807063 |
| Jan 21, 2021 | Lanester, France | Drugs | Voluntary Action Indicated (VAI) | 3002807063 |
| Feb 13, 2015 | Princeton, NJ | Drugs | No Action Indicated (NAI) | 3014243475 |
| Jan 14, 2013 | Princeton, NJ | Drugs | No Action Indicated (NAI) | 3014243475 |
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.