Elite Spine LLC, Collegeville, PA – FDA Inspections

Inspection records and compliance data for Elite Spine LLC in Collegeville, Pennsylvania. 3 FDA inspections on record, 1 Form 483, last inspected August 21, 2023.

Company Profile

This profile covers Elite Spine LLC based in Collegeville, Pennsylvania, United States.

FDA Inspection History

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

First inspected November 16, 2016. Last inspected August 21, 2023.

Most cited issue areas

All core requirements covered in program1 inspection
Procedures re complaints1 inspection
Procedures to meet core CTGP1 inspection

FDA inspections (3)

Date	Result	FDA center(s)	Insp. #
August 21, 2023	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1220146
June 15, 2017	NAI	Biologics · Human Cellular, Tissue, and Gene Therapies	1018942
November 16, 2016	NAI	Biologics · Blood and Blood Products	992243

FDA documents

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

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