Gulf Coast Regional Blood Center At Baytown FDA Record
- Latest inspection NAI · Apr 28, 2022
- No warning letters matched by name
Gulf Coast Regional Blood Center At Baytown has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gulf Coast Regional Blood Center At Baytown" is on file.
- Latest inspection
- Apr 28, 2022 · NAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 6 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Gulf Coast Regional Blood Center At Baytown: 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 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 28, 2022 | Baytown, TX | Biologics | No Action Indicated (NAI) | 3007220727 |
| May 31, 2018 | Baytown, TX | Biologics | No Action Indicated (NAI) | 3007220727 |
| Nov 3, 2015 | Baytown, TX | Biologics | No Action Indicated (NAI) | 3007220727 |
| Dec 12, 2013 | Baytown, TX | Biologics | No Action Indicated (NAI) | 3007220727 |
| Dec 7, 2011 | Baytown, TX | Biologics | No Action Indicated (NAI) | 3007220727 |
| Oct 27, 2009 | Baytown, TX | Biologics | No Action Indicated (NAI) | 3007220727 |
- 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 3007220727 | Baytown, TX | 6 | Apr 28, 2022 |
Gulf Coast Regional Blood Center At Baytown and the FDA: common questions
Has Gulf Coast Regional Blood Center At Baytown received an FDA warning letter?
No FDA warning letter addressed to the name "Gulf Coast Regional Blood Center At Baytown" 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 Gulf Coast Regional Blood Center At Baytown received an FDA Form 483?
FDA has not published a Form 483 for "Gulf Coast Regional Blood Center At Baytown" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Gulf Coast Regional Blood Center At Baytown?
The most recent FDA inspection on file ended Apr 28, 2022 at Baytown, TX and was classified NAI. FDA has 6 inspections of Gulf Coast Regional Blood Center At Baytown on file.
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