Stem Cell Cryo Bank, LLC FDA Record
Stem Cell Cryo Bank, LLC has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Stem Cell Cryo Bank, LLC" is on file.
- Latest inspection
- May 1, 2025 · VAI
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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 | 5 | 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 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 1, 2025 | Deerfield Beach, FL | Biologics | Voluntary Action Indicated (VAI) | 3004355298 |
| Jul 21, 2021 | Deerfield Beach, FL | Biologics | No Action Indicated (NAI) | 3004355298 |
| Aug 2, 2017 | Deerfield Beach, FL | Biologics | No Action Indicated (NAI) | 3004355298 |
| Feb 7, 2012 | Deerfield Beach, FL | Biologics | No Action Indicated (NAI) | 3004355298 |
| Jun 18, 2009 | Deerfield Beach, FL | Biologics | Voluntary Action Indicated (VAI) | 3004355298 |
- 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 3004355298 | Deerfield Beach, FL | 5 | May 1, 2025 |
Stem Cell Cryo Bank, LLC and the FDA: common questions
Has Stem Cell Cryo Bank, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Stem Cell Cryo Bank, LLC" 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 Stem Cell Cryo Bank, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Stem Cell Cryo Bank, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Stem Cell Cryo Bank, LLC?
The most recent FDA inspection on file ended May 1, 2025 at Deerfield Beach, FL and was classified VAI. FDA has 5 inspections of Stem Cell Cryo Bank, LLC on file.
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