J4 Biologics LLC FDA Record
J4 Biologics LLC has 0 FDA recalls, 1 inspection, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "J4 Biologics LLC" is on file.
- Latest inspection
- Apr 25, 2025 · NAI
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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 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 25, 2025 | San Antonio, TX | Biologics | No Action Indicated (NAI) | 3025971176 |
- 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 3025971176 | San Antonio, TX | 1 | Apr 25, 2025 |
J4 Biologics LLC and the FDA: common questions
Has J4 Biologics LLC received an FDA warning letter?
No FDA warning letter addressed to the name "J4 Biologics 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 J4 Biologics LLC received an FDA Form 483?
FDA has not published a Form 483 for "J4 Biologics LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect J4 Biologics LLC?
The most recent FDA inspection on file ended Apr 25, 2025 at San Antonio, TX and was classified NAI. FDA has 1 inspection of J4 Biologics LLC on file.
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