Pure Life Orthopedic LLC – FDA Inspection, Jan 30, 2024

Record Details

This FDA Inspection record concerns Pure Life Orthopedic LLC, with an inspection on January 30, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Pure Life Orthopedic LLC
Inspection Date: January 30, 2024
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Laura E. Garcia (Issuing Officer)

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ID · 2529ce45-bfc6-465d-8d6a-2b55b69c9086

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1228117
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies

FDA Citations

21 CFR 1271.265(f)Return to inventory--procedures
21 CFR 1271.320(a)Procedures re complaints

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FDA Inspection

Pure Life Orthopedic LLCJanuary 30, 2024