Biomat Holdings Mount Vernon Newark FDA Record
- Latest inspection VAI · Jul 15, 2025
- No warning letters matched by name
Biomat Holdings Mount Vernon Newark has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Biomat Holdings Mount Vernon Newark" is on file.
- Latest inspection
- Jul 15, 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 | 1 | 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 |
|---|---|---|---|---|
| Jul 15, 2025 | Newark, OH | Biologics | Voluntary Action Indicated (VAI) | 3029965162 |
- 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 3029965162 | Newark, OH | 1 | Jul 15, 2025 |
Biomat Holdings Mount Vernon Newark and the FDA: common questions
Has Biomat Holdings Mount Vernon Newark received an FDA warning letter?
No FDA warning letter addressed to the name "Biomat Holdings Mount Vernon Newark" 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 Biomat Holdings Mount Vernon Newark received an FDA Form 483?
FDA has not published a Form 483 for "Biomat Holdings Mount Vernon Newark" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Biomat Holdings Mount Vernon Newark?
The most recent FDA inspection on file ended Jul 15, 2025 at Newark, OH and was classified VAI. FDA has 1 inspection of Biomat Holdings Mount Vernon Newark on file.
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