Hospital For Special Surgery IRB FDA Record
Hospital For Special Surgery IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Hospital For Special Surgery IRB" is on file.
- Latest inspection
- Apr 30, 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 | 3 | 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 | 0 | 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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 30, 2025 | New York, NY | Devices | No Action Indicated (NAI) | 2434097 |
| May 25, 2017 | New York, NY | Drugs | No Action Indicated (NAI) | 2434097 |
| Jul 7, 2011 | New York, NY | Drugs | Voluntary Action Indicated (VAI) | 2434097 |
- 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 2434097 | New York, NY | 3 | Apr 30, 2025 |
Hospital For Special Surgery IRB and the FDA: common questions
Has Hospital For Special Surgery IRB received an FDA warning letter?
No FDA warning letter addressed to the name "Hospital For Special Surgery IRB" 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 Hospital For Special Surgery IRB received an FDA Form 483?
FDA has not published a Form 483 for "Hospital For Special Surgery IRB" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Hospital For Special Surgery IRB?
The most recent FDA inspection on file ended Apr 30, 2025 at New York, NY and was classified NAI. FDA has 3 inspections of Hospital For Special Surgery IRB on file.
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