BioGenetics Corporation FDA Record
BioGenetics Corporation has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "BioGenetics Corporation" is on file.
- Latest inspection
- Mar 14, 2025 · 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 | 8 | 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 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Mar 14, 2025 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Sep 5, 2023 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Nov 12, 2019 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Jul 10, 2018 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Aug 19, 2016 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Nov 14, 2013 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Apr 23, 2012 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
| Feb 18, 2010 | Mountainside, NJ | Biologics | No Action Indicated (NAI) | 3001236618 |
- 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 3001236618 | Mountainside, NJ | 8 | Mar 14, 2025 |
BioGenetics Corporation and the FDA: common questions
Has BioGenetics Corporation received an FDA warning letter?
No FDA warning letter addressed to the name "BioGenetics Corporation" 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 BioGenetics Corporation received an FDA Form 483?
FDA has not published a Form 483 for "BioGenetics Corporation" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect BioGenetics Corporation?
The most recent FDA inspection on file ended Mar 14, 2025 at Mountainside, NJ and was classified NAI. FDA has 8 inspections of BioGenetics Corporation on file.
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