Aytu Biopharma, Inc. – FDA Inspection, Sep 25, 2026

Record Details

This FDA Inspection record concerns Aytu Biopharma, Inc., with an inspection on September 25, 2026, issued by the Denver District Office, covering human drugs.

Company: Aytu Biopharma, Inc.
Inspection Date: September 25, 2026
Product Type: Human Drugs
Office: Denver District Office
People: Theressa B. Smith (Issuing Officer)
Veronica L. Bush (Issuing Officer)

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ID · 1f5815cf-23f3-4770-9b5b-13ddd51a5762

Inspection Facts

Inspection number: 1338580
FDA center: Human Drugs
Project area: Postmarket Surv. and Epidemiology
Outcome: Form 483 issued

FDA Citations

21 CFR 314.80(b)Failure to develop written procedures
21 CFR 314.80(f)(5)Inconsistent unique case identification number ICSR
21 CFR 314.80(j)Failure to maintain records

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FDA Inspection

Aytu Biopharma, Inc.September 25, 2026