Boston IVF FDA Record
- Latest inspection NAI · Sep 19, 2024
- No warning letters matched by name
Boston IVF has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Boston IVF" is on file.
- Latest inspection
- Sep 19, 2024 · NAI
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 | 11 | 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
Boston IVF: 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 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 1 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2017 | 2 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Sep 19, 2024 | Waltham, MA | Biologics | No Action Indicated (NAI) | 3004514164 |
| Jan 9, 2020 | Lexington, MA | Biologics | No Action Indicated (NAI) | 3003928198 |
| Dec 6, 2019 | Waltham, MA | Biologics | No Action Indicated (NAI) | 3004514164 |
| Dec 13, 2017 | Lexington, MA | Biologics | No Action Indicated (NAI) | 3003928198 |
| Jul 21, 2017 | Waltham, MA | Biologics | No Action Indicated (NAI) | 3004514164 |
| Aug 31, 2015 | Lexington, MA | Biologics | No Action Indicated (NAI) | 3003928198 |
| Apr 16, 2014 | Waltham, MA | Biologics | No Action Indicated (NAI) | 3004514164 |
| Mar 27, 2013 | Lexington, MA | Biologics | No Action Indicated (NAI) | 3003928198 |
| Nov 18, 2011 | Waltham, MA | Biologics | No Action Indicated (NAI) | 3004514164 |
| Sep 13, 2010 | Waltham, MA | Biologics | No Action Indicated (NAI) | 3004514164 |
| Sep 1, 2010 | Lexington, MA | Biologics | No Action Indicated (NAI) | 3003928198 |
- 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 3004514164 | Waltham, MA | 6 | Sep 19, 2024 |
| FEI 3003928198 | Lexington, MA | 5 | Jan 9, 2020 |
Boston IVF and the FDA: common questions
Has Boston IVF received an FDA warning letter?
No FDA warning letter addressed to the name "Boston IVF" 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 Boston IVF received an FDA Form 483?
FDA has not published a Form 483 for "Boston IVF" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Boston IVF?
The most recent FDA inspection on file ended Sep 19, 2024 at Waltham, MA and was classified NAI. FDA has 11 inspections of Boston IVF on file.
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