Island Reproductive Services FDA Record
Island Reproductive Services has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Island Reproductive Services" is on file.
- Latest inspection
- Apr 17, 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 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 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 | 1 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 17, 2025 | Staten Island, NY | Biologics | No Action Indicated (NAI) | 3011393636 |
| Jan 26, 2023 | Staten Island, NY | Biologics | No Action Indicated (NAI) | 3011393636 |
| Sep 12, 2019 | Staten Island, NY | Biologics | No Action Indicated (NAI) | 3011393636 |
| Feb 16, 2017 | Staten Island, NY | Biologics | No Action Indicated (NAI) | 3011393636 |
| Apr 14, 2015 | Staten Island, NY | Biologics | Voluntary Action Indicated (VAI) | 3011393636 |
| May 3, 2013 | Staten Island, NY | Biologics | No Action Indicated (NAI) | 3011393636 |
| Feb 24, 2011 | Staten Island, NY | Biologics | No Action Indicated (NAI) | 3011393636 |
- 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 3011393636 | Staten Island, NY | 7 | Apr 17, 2025 |
Island Reproductive Services and the FDA: common questions
Has Island Reproductive Services received an FDA warning letter?
No FDA warning letter addressed to the name "Island Reproductive Services" 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 Island Reproductive Services received an FDA Form 483?
FDA has not published a Form 483 for "Island Reproductive Services" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Island Reproductive Services?
The most recent FDA inspection on file ended Apr 17, 2025 at Staten Island, NY and was classified NAI. FDA has 7 inspections of Island Reproductive Services on file.
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