FDA Inspection 1303696 — Helena C. Chang, MD

Helena C. Chang, MD — FEI 3041671258

The FDA completed an inspection of Helena C. Chang, MD on Feb 20, 2026 in Santa Clara, 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
Feb 20, 2026
Fiscal Year
2026
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Santa Clara, CA (United States)

Additional details

Clinical Investigator (CI)

Citations

IDCFRDescription
298121 CFR 812.140(a)(2)(i)Investigator device accountability inadequate

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