FDA Inspection 1082190 — CARDIOBIOMEDICAL CORPORATION

CARDIOBIOMEDICAL CORPORATION — FEI 3013023596

The FDA completed an inspection of CARDIOBIOMEDICAL CORPORATION on Mar 8, 2019 in Duarte, CA. 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
Mar 8, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Duarte, CA (United States)

Citations

IDCFRDescription
237121 CFR 820.30(a)Design control - no procedures

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