Three Rivers Orthopaedics & Spine Products, Inc. – FDA Inspection, Dec 22, 2008

Record Details

This FDA Inspection record concerns Three Rivers Orthopaedics & Spine Products, Inc., with an inspection on December 22, 2008, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Three Rivers Orthopaedics & Spine Products, Inc.
Inspection Date: December 22, 2008
Product Type: Biologics
Office: Center for Biologics Evaluation and Research

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ID · 6b9063ce-9d9d-4ead-905c-2e47a75edcd2

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 551867
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies

FDA Citations

21 CFR 1271.160(a)All core requirements covered in program
21 CFR 1271.195(d)Documentation not maintained
21 CFR 1271.320(a)Procedures re complaints

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FDA Inspection

Three Rivers Orthopaedics & Spine Products, Inc.December 22, 2008