Banco De Sangre Humacao, Inc. FDA Record
Banco De Sangre Humacao, Inc. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Banco De Sangre Humacao, Inc." is on file.
- Latest inspection
- Jun 23, 2025 · NAI
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 | 6 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 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 |
|---|---|---|---|---|
| Jun 23, 2025 | Humacao, PR | Biologics | No Action Indicated (NAI) | 1000110318 |
| Jul 21, 2022 | Humacao, PR | Biologics | Voluntary Action Indicated (VAI) | 1000110318 |
| May 1, 2018 | Humacao, PR | Biologics | No Action Indicated (NAI) | 1000110318 |
| Jul 3, 2013 | Humacao, PR | Biologics | Voluntary Action Indicated (VAI) | 1000110318 |
| Mar 30, 2011 | Humacao, PR | Biologics | No Action Indicated (NAI) | 1000110318 |
| Aug 7, 2009 | Humacao, PR | Biologics | Voluntary Action Indicated (VAI) | 1000110318 |
- 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 1000110318 | Humacao, PR | 6 | Jun 23, 2025 |
Banco De Sangre Humacao, Inc. and the FDA: common questions
Has Banco De Sangre Humacao, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Banco De Sangre Humacao, 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 Banco De Sangre Humacao, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Banco De Sangre Humacao, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Banco De Sangre Humacao, Inc.?
The most recent FDA inspection on file ended Jun 23, 2025 at Humacao, PR and was classified NAI. FDA has 6 inspections of Banco De Sangre Humacao, Inc. on file.
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