Gulf Coast Regional Blood Center At Westchase FDA Record
- Latest inspection NAI · Sep 12, 2024
- No warning letters matched by name
Gulf Coast Regional Blood Center At Westchase has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Gulf Coast Regional Blood Center At Westchase" is on file.
- Latest inspection
- Sep 12, 2024 · 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 | 7 | 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 Westchase: 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 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 12, 2024 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
| Jun 14, 2019 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
| Feb 7, 2017 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
| Apr 15, 2015 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
| Oct 11, 2012 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
| Nov 22, 2010 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
| Jan 30, 2009 | Houston, TX | Biologics | No Action Indicated (NAI) | 3006799214 |
- 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 3006799214 | Houston, TX | 7 | Sep 12, 2024 |
Gulf Coast Regional Blood Center At Westchase and the FDA: common questions
Has Gulf Coast Regional Blood Center At Westchase received an FDA warning letter?
No FDA warning letter addressed to the name "Gulf Coast Regional Blood Center At Westchase" 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 Westchase received an FDA Form 483?
FDA has not published a Form 483 for "Gulf Coast Regional Blood Center At Westchase" 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 Westchase?
The most recent FDA inspection on file ended Sep 12, 2024 at Houston, TX and was classified NAI. FDA has 7 inspections of Gulf Coast Regional Blood Center At Westchase on file.
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