FDA Inspection 1009920 — Sterigenics US LLC

Sterigenics US LLC — FEI 1526534

The FDA completed an inspection of Sterigenics US LLC on Apr 26, 2017 in Lewis Center, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Apr 26, 2017
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Lewis Center, OH (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.