Elite Orthopedics, LLC, Chesterfield, MO – FDA Inspections

Inspection records and compliance data for Elite Orthopedics, LLC in Chesterfield, Missouri. 4 FDA inspections on record, last inspected January 15, 2020.

Company Profile

This profile covers Elite Orthopedics, LLC based in Chesterfield, Missouri, United States.

FDA Inspection History

FDA inspections: 4
OAI: 0
VAI: 1
NAI: 3
Form 483s: 0
Warning letters: 0

First inspected December 10, 2012. Last inspected January 15, 2020.

Most cited issue areas

Program is appropriate for the HCT/Ps1 inspection
Storage temperatures recorded, maintained1 inspection

FDA inspections (4)

Date	Result	FDA center(s)	Insp. #
January 15, 2020	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1115847
April 5, 2018	NAI	Biologics · Blood and Blood Products	1049449
December 4, 2015	VAI	Biologics · Human Cellular, Tissue, and Gene Therapies	951965
December 10, 2012	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	812513

FDA documents

No Form 483s, Warning Letters or EIRs on record.

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