PURIBLOOD MEDICAL CO., LTD FDA Record
PURIBLOOD MEDICAL CO., LTD has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "PURIBLOOD MEDICAL CO., LTD" is on file. FDA has published 1 Form 483 for PURIBLOOD MEDICAL CO., LTD.
- Latest inspection
- Mar 14, 2025 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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PURIBLOOD MEDICAL CO., LTD Form 483s
| Date | Document | FEI |
|---|---|---|
| Mar 14, 2025 · Document on fda.gov | 483 | 3015169752 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Hsinchu County, Taiwan | Biologics | Voluntary Action Indicated (VAI) | 3015169752 |
- 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 3015169752 | Hsinchu County, Taiwan | 1 | Mar 14, 2025 |
PURIBLOOD MEDICAL CO., LTD and the FDA: common questions
Has PURIBLOOD MEDICAL CO., LTD received an FDA warning letter?
No FDA warning letter addressed to the name "PURIBLOOD MEDICAL CO., LTD" 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 PURIBLOOD MEDICAL CO., LTD received an FDA Form 483?
FDA has published 1 Form 483 for PURIBLOOD MEDICAL CO., LTD in its reading room, the most recent dated Mar 14, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect PURIBLOOD MEDICAL CO., LTD?
The most recent FDA inspection on file ended Mar 14, 2025 at Hsinchu County, Taiwan and was classified VAI. FDA has 1 inspection of PURIBLOOD MEDICAL CO., LTD on file.
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