Xtent BioMedical LLC – FDA Inspection, Mar 5, 2026

Record Details

This FDA Inspection record concerns Xtent BioMedical LLC, with an inspection on March 5, 2026, issued by the New Orleans District Office, covering biologics.

Company: Xtent BioMedical LLC
Inspection Date: March 5, 2026
Product Type: Biologics
Office: New Orleans District Office
People: Laressa R. Gray (Issuing Officer)
Laurissa S. Flowers (Issuing Officer)

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ID · 8d5afdd1-8798-457e-9434-c489c78485a1

Inspection Facts

Inspection number: 1306782
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies
Outcome: Form 483 issued

FDA Citations

21 CFR 1271.195(a)Adequate control, proper conditions
21 CFR 1271.200(b)Procedures inadequate
21 CFR 1271.260(a)Contamination, mix ups, improper release

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FDA Inspection

Xtent BioMedical LLCMarch 5, 2026