FDA Inspection 871691 — Kyocera Corporation

Kyocera Corporation — FEI 3010566635

The FDA completed an inspection of Kyocera Corporation on Feb 28, 2014 in Kyoto. 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 28, 2014
Fiscal Year
2014
Product Type
Devices
Project Area
Compliance: Devices
Location
Kyoto (Japan)

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
232721 CFR 820.22Quality audits - Lack of or inadequate procedures

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