Aeon Biotherapeutics Corp.
Form 483 issued March 7, 2025
- Inspection
- Mar 3 – Mar 7, 2025
- Investigators
- Creighton T. Tuzon· Nisha C. Patel
- Observations
- 4
- Pages
- 6
- FEI number
- 3019027610
In short: On March 7, 2025, FDA issued a Form 483 with 4 observations to Aeon Biotherapeutics Corp. (FEI 3019027610) after an inspection that ran Mar 3 – Mar 7, 2025. The investigators were Creighton T. Tuzon and Nisha C. Patel. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
3 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Products that do not conform to specifications…
- 03
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 04
Procedures foM of nonconforming product have not been adequately…
This inspection in context
Creighton T. Tuzon
6 documents · 2020–2025
Cites 1271.47 (what procedures must i establish and maintain?) more than any other section. Most of their documents are for sites in California.
The firmAeon Biotherapeutics Corp. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Aeon Biotherapeutics Corp.?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Aeon Biotherapeutics Corp.?
Creighton T. Tuzon and Nisha C. Patel are named on this Form 483, for the inspection of Mar 3 – Mar 7, 2025. Each investigator has a profile showing what they cite most.
When was Aeon Biotherapeutics Corp. inspected by FDA?
The inspection ran Mar 3 – Mar 7, 2025, and the Form 483 is dated March 7, 2025.
How do I get the full Form 483 for Aeon Biotherapeutics Corp.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.