HealthOne Swedish Medical Center Blood Bank FDA Record
- Latest inspection VAI · Sep 22, 2014
- No warning letters matched by name
HealthOne Swedish Medical Center Blood Bank has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "HealthOne Swedish Medical Center Blood Bank" is on file.
- Latest inspection
- Sep 22, 2014 · VAI
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 | 1 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 22, 2014 | Englewood, CO | Biologics | Voluntary Action Indicated (VAI) | 1773511 |
- 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 1773511 | Englewood, CO | 1 | Sep 22, 2014 |
HealthOne Swedish Medical Center Blood Bank and the FDA: common questions
Has HealthOne Swedish Medical Center Blood Bank received an FDA warning letter?
No FDA warning letter addressed to the name "HealthOne Swedish Medical Center Blood Bank" 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 HealthOne Swedish Medical Center Blood Bank received an FDA Form 483?
FDA has not published a Form 483 for "HealthOne Swedish Medical Center Blood Bank" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect HealthOne Swedish Medical Center Blood Bank?
The most recent FDA inspection on file ended Sep 22, 2014 at Englewood, CO and was classified VAI. FDA has 1 inspection of HealthOne Swedish Medical Center Blood Bank on file.
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