Aeon Biotherapeutics Corp. – FDA Inspection, Mar 7, 2025

Record Details

This FDA Inspection record concerns Aeon Biotherapeutics Corp., with an inspection on March 7, 2025, issued by the Office of Inspections and Investigations, covering biologics.

Company: Aeon Biotherapeutics Corp.
Inspection Date: March 7, 2025
Product Type: Biologics
Office: Office of Inspections and Investigations
People: Alexander M. Kay (Company Rep)
Creighton T. Tuzon (Issuing Officer)
Nisha C. Patel (Issuing Officer)

View Company Profile

ID · 7b2d43e4-f8d8-4fe0-a0f2-5b7d8409b671

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 1265004
FDA center: Biologics
Project area: Blood and Blood Products
Outcome: Form 483 issued, view the record

FDA Citations

21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
21 CFR 820.90(a)Nonconforming product control

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Aeon Biotherapeutics Corp.

FDA Inspection

Aeon Biotherapeutics Corp.March 7, 2025