FDA Inspection 644445 — Isomedix Operations Inc

Isomedix Operations Inc — FEI 1526711

The FDA completed an inspection of Isomedix Operations Inc on January 27, 2010 in Groveport, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
January 27, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Groveport, OH (United States)

Citations

IDCFRDescription
369021 CFR 820.100(a)(3)Identification of actions needed
369421 CFR 820.100(a)(6)Dissemination of problem information
369621 CFR 820.100(b)Documentation