1265004

Aeon Biotherapeutics Corp. — FEI 3019027610

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 7, 2025
Fiscal Year
2025
Product Type
Biologics
Project Area
Blood and Blood Products
Location
New Taipei City (Taiwan)

Citations

IDCFRDescription
310821 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
312821 CFR 820.90(a)Nonconforming product control
313021 CFR 820.100(a)Lack of or inadequate procedures
328521 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures