Nielsen Biosciences, Inc FDA Record
Nielsen Biosciences, Inc has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Nielsen Biosciences, Inc" is on file.
- Latest inspection
- Apr 17, 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 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 17, 2025 | San Diego, CA | Biologics | Voluntary Action Indicated (VAI) | 3010849583 |
| Apr 17, 2025 | San Diego, CA | Biologics | No Action Indicated (NAI) | 3014246807 |
- 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 3010849583 | San Diego, CA | 1 | Apr 17, 2025 |
| FEI 3014246807 | San Diego, CA | 1 | Apr 17, 2025 |
Nielsen Biosciences, Inc and the FDA: common questions
Has Nielsen Biosciences, Inc received an FDA warning letter?
No FDA warning letter addressed to the name "Nielsen Biosciences, Inc" 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 Nielsen Biosciences, Inc received an FDA Form 483?
FDA has not published a Form 483 for "Nielsen Biosciences, Inc" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Nielsen Biosciences, Inc?
The most recent FDA inspection on file ended Apr 17, 2025 at San Diego, CA and was classified VAI. FDA has 2 inspections of Nielsen Biosciences, Inc on file.
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