Lifetek Orthobiologics, LLC FDA Record
Lifetek Orthobiologics, LLC has 0 FDA recalls, 2 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lifetek Orthobiologics, LLC" is on file.
- Latest inspection
- Aug 8, 2011 · 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 | 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 |
|---|---|---|---|---|
| Aug 8, 2011 | Newberry, FL | Biologics | No Action Indicated (NAI) | 3003712702 |
| May 9, 2011 | Newberry, FL | Biologics | No Action Indicated (NAI) | 3003712702 |
- 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 3003712702 | Newberry, FL | 2 | Aug 8, 2011 |
Lifetek Orthobiologics, LLC and the FDA: common questions
Has Lifetek Orthobiologics, LLC received an FDA warning letter?
No FDA warning letter addressed to the name "Lifetek Orthobiologics, 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 Lifetek Orthobiologics, LLC received an FDA Form 483?
FDA has not published a Form 483 for "Lifetek Orthobiologics, LLC" in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Lifetek Orthobiologics, LLC?
The most recent FDA inspection on file ended Aug 8, 2011 at Newberry, FL and was classified NAI. FDA has 2 inspections of Lifetek Orthobiologics, LLC on file.
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