Family Fertility Center FDA Record
- Latest inspection NAI · Jan 5, 2026
- Last warning letter 2019
Family Fertility Center has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Family Fertility Center, the most recent on Sep 30, 2019.
- Latest inspection
- Jan 5, 2026 · 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 | 11 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Family Fertility Center: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 1 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 1 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Family Fertility Center FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Sep 30, 2019 · Letter on fda.gov | Division of Biological Products Operations II |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jan 5, 2026 | Bethlehem, PA | Biologics | No Action Indicated (NAI) | 3003939664 |
| Jan 30, 2024 | Houston, TX | Biologics | No Action Indicated (NAI) | 3003926820 |
| Mar 16, 2020 | Houston, TX | Biologics | Voluntary Action Indicated (VAI) | 3003926820 |
| Jun 26, 2019 | Houston, TX | Biologics | Official Action Indicated (OAI) | 3003926820 |
| Feb 6, 2018 | Bethlehem, PA | Biologics | No Action Indicated (NAI) | 3003939664 |
| Apr 20, 2016 | Bethlehem, PA | Biologics | No Action Indicated (NAI) | 3003939664 |
| May 6, 2015 | Houston, TX | Biologics | No Action Indicated (NAI) | 3003926820 |
| Mar 27, 2014 | Bethlehem, PA | Biologics | No Action Indicated (NAI) | 3003939664 |
| May 23, 2012 | Houston, TX | Biologics | No Action Indicated (NAI) | 3003926820 |
| Dec 14, 2011 | Bethlehem, PA | Biologics | No Action Indicated (NAI) | 3003939664 |
| Mar 18, 2009 | Bethlehem, PA | Biologics | No Action Indicated (NAI) | 3003939664 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Family Fertility Center: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3003939664 | Bethlehem, PA | 6 | Jan 5, 2026 |
| FEI 3003926820 | Houston, TX | 5 | Jan 30, 2024 |
Family Fertility Center and the FDA: common questions
Has Family Fertility Center received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Family Fertility Center. The most recent is dated Sep 30, 2019.
Has Family Fertility Center received an FDA Form 483?
FDA has not published a Form 483 for "Family Fertility Center" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Family Fertility Center?
The most recent FDA inspection on file ended Jan 5, 2026 at Bethlehem, PA and was classified NAI. FDA has 11 inspections of Family Fertility Center on file, 1 of them classified OAI (official action indicated).
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