Stony Brook Community Medical PC - Island Fertility FDA Record
- Latest inspection VAI · May 28, 2024
- No warning letters matched by name
Stony Brook Community Medical PC - Island Fertility has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Stony Brook Community Medical PC - Island Fertility" is on file.
- Latest inspection
- May 28, 2024 · VAI
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 0 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 3 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Stony Brook Community Medical PC - Island Fertility: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 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 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 28, 2024 | Commack, NY | Biologics | Voluntary Action Indicated (VAI) | 3015335677 |
| Jul 13, 2022 | Commack, NY | Biologics | Voluntary Action Indicated (VAI) | 3015335677 |
| Jul 30, 2021 | Commack, NY | Biologics | No Action Indicated (NAI) | 3015335677 |
- 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 3015335677 | Commack, NY | 3 | May 28, 2024 |
Stony Brook Community Medical PC - Island Fertility and the FDA: common questions
Has Stony Brook Community Medical PC - Island Fertility received an FDA warning letter?
No FDA warning letter addressed to the name "Stony Brook Community Medical PC - Island Fertility" 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 Stony Brook Community Medical PC - Island Fertility received an FDA Form 483?
FDA has not published a Form 483 for "Stony Brook Community Medical PC - Island Fertility" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Stony Brook Community Medical PC - Island Fertility?
The most recent FDA inspection on file ended May 28, 2024 at Commack, NY and was classified VAI. FDA has 3 inspections of Stony Brook Community Medical PC - Island Fertility on file.
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