Ossium Health Inc – FDA Inspection, May 30, 2024

Record Details

This FDA Inspection record concerns Ossium Health Inc, with an inspection on May 30, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Ossium Health Inc
Inspection Date: May 30, 2024
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
Person: Lesley Mae P. Lutao (Investigator)

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ID · 626087c8-75f6-447a-bfea-e462504fe310

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1237925
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies

FDA Citations

21 CFR 1271.270(a)Records maintained concurrently
21 CFR 1271.220(c)Specified requirements for in-process controls

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FDA Inspection

Ossium Health IncMay 30, 2024