Global Premier Fertility Orange County LLC FDA Record
Global Premier Fertility Orange County LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Global Premier Fertility Orange County LLC" is on file. FDA has published 1 Form 483 for Global Premier Fertility Orange County LLC.
- Latest inspection
- Apr 11, 2025 · VAI
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 | 2 | 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 | 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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Global Premier Fertility Orange County LLC Form 483s
| Date | Document | FEI |
|---|---|---|
| Apr 11, 2025 | 483 | 3018118424 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 11, 2025 | Newport Beach, CA | Biologics | Voluntary Action Indicated (VAI) | 3018118424 |
| Oct 8, 2021 | Newport Beach, CA | Biologics | No Action Indicated (NAI) | 3018118424 |
- 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 3018118424 | Newport Beach, CA | 2 | Apr 11, 2025 |
Global Premier Fertility Orange County LLC and the FDA: common questions
Has Global Premier Fertility Orange County LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Global Premier Fertility Orange County LLC" 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 Global Premier Fertility Orange County LLC received an FDA Form 483?
FDA has published 1 Form 483 for Global Premier Fertility Orange County LLC in its reading room, the most recent dated Apr 11, 2025. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Global Premier Fertility Orange County LLC?
The most recent FDA inspection on file ended Apr 11, 2025 at Newport Beach, CA and was classified VAI. FDA has 2 inspections of Global Premier Fertility Orange County LLC on file.
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