Lopez Gonzalez Santana Corporation
FDA Regulatory Profile
Lopez Gonzalez Santana Corporation has 5 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- F-0666-2021 · Class III · May 25, 2021
- Latest inspection
- Nov 13, 2023 · VAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 5 | 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 | 7 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| F-0666-2021 | Class III | BTREX PLUS, Dietary Supplement 2 caplets bottles, UPC 05380930802 (Physician Samples) | May 25, 2021 |
| F-0665-2021 | Class III | BTREX PLUS, Dietary Supplement 100 Caplets, UPC 05380930801 | May 25, 2021 |
| F-0484-2021 | Class III | BTREX PLUS, Dietary Supplement 100 Caplets | Apr 20, 2021 |
| F-0540-2021 | Class III | BTREX PLUS, Dietary Supplement 2 Caplets, UPC 05380930802 (Physician Samples) | Jul 13, 2020 |
| F-0541-2021 | Class III | BTREX PLUS, Dietary Supplement 100 Caplets | Jul 13, 2020 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|
| Nov 13, 2023 | Rio Piedras, PR | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2650148 |
| Jan 26, 2023 | Rio Piedras, PR | Food/Cosmetics | Official Action Indicated (OAI) | 2650148 |
| Apr 13, 2021 | Rio Piedras, PR | Food/Cosmetics | Official Action Indicated (OAI) | 2650148 |
| Aug 17, 2018 | Rio Piedras, PR | Food/Cosmetics | Official Action Indicated (OAI) | 2650148 |
| Feb 10, 2017 | Rio Piedras, PR | Food/Cosmetics | Official Action Indicated (OAI) | 2650148 |
| Sep 22, 2011 | Rio Piedras, PR | Drugs | Voluntary Action Indicated (VAI) | 2650148 |
| Sep 22, 2011 | Rio Piedras, PR | Food/Cosmetics | Voluntary Action Indicated (VAI) | 2650148 |
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.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 2650148 | Rio Piedras, PR | 7 | Nov 13, 2023 |