New York Blood Center, Inc. FDA Record
New York Blood Center, Inc. has 0 FDA recalls, 55 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "New York Blood Center, Inc." is on file.
- Latest inspection
- Jul 17, 2026 · VAI
- Latest 510(k)
- Sep 13, 1989
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 55 | 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 | 3 | 0 | 0 | 0 | 0 |
| 2025 | 2 | 0 | 0 | 0 | 0 |
| 2024 | 2 | 0 | 0 | 0 | 0 |
| 2023 | 2 | 0 | 0 | 0 | 0 |
| 2022 | 2 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 3 | 0 | 0 | 0 | 0 |
| 2018 | 4 | 0 | 0 | 0 | 0 |
| 2017 | 3 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 17, 2026 | New York, NY | Biologics | Voluntary Action Indicated (VAI) | 3002663381 |
| Jun 23, 2026 | Fishkill, NY | Biologics | Voluntary Action Indicated (VAI) | 1000143372 |
| Apr 2, 2026 | Freehold, NJ | Biologics | No Action Indicated (NAI) | 3016373548 |
| Sep 16, 2025 | St. Paul, MN | Biologics | No Action Indicated (NAI) | 2170665 |
| Feb 26, 2025 | Paramus, NJ | Biologics | No Action Indicated (NAI) | 3010484696 |
| Nov 15, 2024 | St. Paul, MN | Biologics | No Action Indicated (NAI) | 2170665 |
| Sep 13, 2024 | Scotch Plains, NJ | Biologics | No Action Indicated (NAI) | 3007921234 |
| Feb 3, 2023 | Fishkill, NY | Biologics | No Action Indicated (NAI) | 1000143372 |
| Jan 19, 2023 | Nanuet, NY | Biologics | No Action Indicated (NAI) | 1000143376 |
| Dec 19, 2022 | New Brunswick, NJ | Biologics | No Action Indicated (NAI) | 2276020 |
| Sep 30, 2022 | New York, NY | Biologics | No Action Indicated (NAI) | 3002663381 |
| Oct 15, 2021 | Freehold, NJ | Biologics | No Action Indicated (NAI) | 3016373548 |
| Jan 24, 2020 | Paramus, NJ | Biologics | No Action Indicated (NAI) | 3010484696 |
| Jun 24, 2019 | New Brunswick, NJ | Biologics | No Action Indicated (NAI) | 2276020 |
| Jun 20, 2019 | St. Paul, MN | Biologics | No Action Indicated (NAI) | 2170665 |
| Jan 30, 2019 | Scotch Plains, NJ | Biologics | No Action Indicated (NAI) | 3007921234 |
| Sep 19, 2018 | New York, NY | Biologics | No Action Indicated (NAI) | 3002663381 |
| Sep 18, 2018 | Paramus, NJ | Biologics | No Action Indicated (NAI) | 3010484696 |
| Aug 6, 2018 | Fishkill, NY | Biologics | No Action Indicated (NAI) | 1000143372 |
| Jul 3, 2018 | Nanuet, NY | Biologics | No Action Indicated (NAI) | 1000143376 |
- 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 3002663381 | New York, NY | 7 | Jul 17, 2026 |
| FEI 1000143372 | Fishkill, NY | 7 | Jun 23, 2026 |
| FEI 3016373548 | Freehold, NJ | 2 | Apr 2, 2026 |
| FEI 2170665 | St. Paul, MN | 10 | Sep 16, 2025 |
| FEI 3010484696 | Paramus, NJ | 5 | Feb 26, 2025 |
| FEI 3007921234 | Scotch Plains, NJ | 6 | Sep 13, 2024 |
| FEI 1000143376 | Nanuet, NY | 7 | Jan 19, 2023 |
| FEI 2276020 | New Brunswick, NJ | 7 | Dec 19, 2022 |
| FEI 3011193649 | Philadelphia, PA | 2 | Nov 21, 2017 |
| FEI 3008927069 | Hartford, CT | 1 | Dec 19, 2011 |
| FEI 3004413818 | Newton, NJ | 1 | Apr 28, 2009 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K894787 | MEL-PAK GENERAL DRUG DELIVERY SYSTEM KIT | Sep 13, 1989 |
New York Blood Center, Inc. and the FDA: common questions
Has New York Blood Center, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "New York Blood Center, 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 New York Blood Center, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "New York Blood Center, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect New York Blood Center, Inc.?
The most recent FDA inspection on file ended Jul 17, 2026 at New York, NY and was classified VAI. FDA has 55 inspections of New York Blood Center, Inc. on file.
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