American Blood Bank Corp. FDA Record
American Blood Bank Corp. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "American Blood Bank Corp." is on file.
- Latest inspection
- Mar 19, 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 | 7 | 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 | 2 | 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 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 19, 2025 | Miami, FL | Biologics | No Action Indicated (NAI) | 3007651216 |
| Jun 14, 2022 | Miami, FL | Biologics | No Action Indicated (NAI) | 3007651216 |
| Jun 13, 2022 | Miami Gardens, FL | Biologics | No Action Indicated (NAI) | 3022938874 |
| Aug 7, 2019 | Miami, FL | Biologics | Voluntary Action Indicated (VAI) | 3007651216 |
| May 19, 2016 | Miami, FL | Biologics | Voluntary Action Indicated (VAI) | 3007651216 |
| Sep 26, 2014 | Miami, FL | Biologics | Voluntary Action Indicated (VAI) | 3007651216 |
| Sep 19, 2012 | Miami, FL | Biologics | No Action Indicated (NAI) | 3007651216 |
- 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 3007651216 | Miami, FL | 6 | Mar 19, 2025 |
| FEI 3022938874 | Miami Gardens, FL | 1 | Jun 13, 2022 |
American Blood Bank Corp. and the FDA: common questions
Has American Blood Bank Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "American Blood Bank Corp." 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 American Blood Bank Corp. received an FDA Form 483?
FDA has not published a Form 483 for "American Blood Bank Corp." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect American Blood Bank Corp.?
The most recent FDA inspection on file ended Mar 19, 2025 at Miami, FL and was classified NAI. FDA has 7 inspections of American Blood Bank Corp. on file.
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