FDA-Inspected Site

Xtent BioMedical LLC

1 FDA inspection is on record for Xtent BioMedical LLC in Bartlett, United States.

483· Form 483 issued

Bartlett, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-03-05.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2026 – 5 Mar 2026Biologics483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

5 Mar 2026
21 CFR 1271.195(a)

Adequate control, proper conditions

Cited by Laurissa S Flowers, Laressa R Gray

5 Mar 2026
21 CFR 1271.200(b)

Procedures inadequate

Cited by Laurissa S Flowers, Laressa R Gray

5 Mar 2026
21 CFR 1271.260(a)

Contamination, mix ups, improper release

Cited by Laurissa S Flowers, Laressa R Gray

Investigators

FDA investigators tied to this site in the record.

Laressa R Gray1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.195(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.200(b)Cited across public-safe Form 483 observations1x
21 CFR 1271.260(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Xtent BioMedical LLC's 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat