FDA Inspection 977456 — UNIVERSITY OF CALIFORNIA, LOS ANGELES

UNIVERSITY OF CALIFORNIA, LOS ANGELES — FEI 3009211584

The FDA completed an inspection of UNIVERSITY OF CALIFORNIA, LOS ANGELES on Jun 2, 2016 in Los Angeles, 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). 6 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 2, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Los Angeles, CA (United States)

Citations

IDCFRDescription
1776321 CFR 212.20(d)Determination need for investigation
1776421 CFR 212.20(e)Written QA procedures established, followed
1778721 CFR 212.40(d)Contamination, mix-ups and deterioration
1782221 CFR 212.50(b)(7)Complete instructions, procedures, specs
1783921 CFR 212.50(c)(11)Results of investigations
1786321 CFR 212.60(g)(3)Complete record of all laboratory test data

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