NOBLE LIFE SCIENCES INC. – FDA Inspection, Jun 20, 2025

Record Details

This FDA Inspection record concerns NOBLE LIFE SCIENCES INC., with an inspection on June 20, 2025, issued by the Baltimore District Office, covering biologics.

Company: NOBLE LIFE SCIENCES INC.
Inspection Date: June 20, 2025
Product Type: Biologics
Office: Baltimore District Office
People: Amanda M. Szucsik (FDA Personnel)
Christine M. Smith (Issuing Officer)
Hugh M. McClure III (Issuing Officer)

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ID · 57dfc328-7f2a-4456-928d-8b10a0c52be4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1273190
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies
Outcome: Form 483 issued

FDA Citations

21 CFR 58.31(f)Management: personnel understand their functions
21 CFR 58.35(b)(5)QAU: authorize deviations from protocols or SOPs
21 CFR 58.90(f)Animal care: cage and equipment cleaning

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FDA Inspection

NOBLE LIFE SCIENCES INC.June 20, 2025