Lopez Gonzalez Santana Corporation FDA Record
- Latest inspection VAI · Nov 13, 2023
- Last warning letter 2017
Lopez Gonzalez Santana Corporation has 5 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Lopez Gonzalez Santana Corporation, the most recent on Aug 28, 2017.
- Latest recall
- F-0666-2021 · Class III · May 25, 2021
- Latest inspection
- Nov 13, 2023 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 5 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 7 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Lopez Gonzalez Santana Corporation: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 2 | 1 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 1 | 0 | 3 | 0 |
| 2020 | 0 | 0 | 0 | 2 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 1 | 0 | 0 | 0 |
| 2017 | 1 | 1 | 1 | 0 | 0 |
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Lopez Gonzalez Santana Corporation FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Aug 28, 2017 · Record page |
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 | Drugs | Voluntary Action Indicated (VAI) | 2650148 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Lopez Gonzalez Santana Corporation: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2650148 | Rio Piedras, PR | 7 | Nov 13, 2023 |
Lopez Gonzalez Santana Corporation and the FDA: common questions
Has Lopez Gonzalez Santana Corporation received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Lopez Gonzalez Santana Corporation. The most recent is dated Aug 28, 2017.
Has Lopez Gonzalez Santana Corporation received an FDA Form 483?
FDA has not published a Form 483 for "Lopez Gonzalez Santana Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Lopez Gonzalez Santana Corporation?
The most recent FDA inspection on file ended Nov 13, 2023 at Rio Piedras, PR and was classified VAI. FDA has 7 inspections of Lopez Gonzalez Santana Corporation on file, 4 of them classified OAI (official action indicated).
Has Lopez Gonzalez Santana Corporation had an FDA recall?
Yes. Lopez Gonzalez Santana Corporation has 5 FDA recalls on record. The most recent started May 25, 2021.
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