GVS TM, Inc FDA Record
GVS TM, Inc has 1 FDA recall, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "GVS TM, Inc" is on file.
- Latest recall
- Z-1157-2026 · Class II · Nov 3, 2025
- Latest inspection
- May 1, 2026 · OAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 1 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 8 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 1 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 1 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1157-2026 | Class II | SQ40S Blood Transfusion Filter | Nov 3, 2025 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 1, 2026 | Covina, CA | Biologics | Official Action Indicated (OAI) | 2013342 |
| Sep 22, 2023 | Covina, CA | Biologics | No Action Indicated (NAI) | 2013342 |
| Sep 25, 2019 | Covina, CA | Drugs | Voluntary Action Indicated (VAI) | 2013342 |
| May 15, 2018 | Covina, CA | Drugs | Voluntary Action Indicated (VAI) | 2013342 |
| Aug 19, 2014 | Covina, CA | Drugs | No Action Indicated (NAI) | 2013342 |
| Nov 8, 2012 | Covina, CA | Drugs | Voluntary Action Indicated (VAI) | 2013342 |
| Mar 18, 2011 | Covina, CA | Drugs | No Action Indicated (NAI) | 2013342 |
| Jun 25, 2010 | Covina, CA | Devices | No Action Indicated (NAI) | 2013342 |
- 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.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2013342 | Covina, CA | 8 | May 1, 2026 |
GVS TM, Inc and the FDA: common questions
Has GVS TM, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "GVS TM, Inc" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has GVS TM, Inc received an FDA Form 483?
FDA has not published a Form 483 for "GVS TM, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect GVS TM, Inc?
The most recent FDA inspection on file ended May 1, 2026 at Covina, CA and was classified OAI. FDA has 8 inspections of GVS TM, Inc on file, 1 of them classified OAI (official action indicated).
Has GVS TM, Inc had an FDA recall?
Yes. GVS TM, Inc has 1 FDA recall on record. The most recent started Nov 3, 2025.
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