FDA Inspection 987449 — ROIS Phoenix Inc

ROIS Phoenix Inc — FEI 3006441852

The FDA completed an inspection of ROIS Phoenix Inc on Jun 24, 2016 in Phoenix, AZ. 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). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jun 24, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Phoenix, AZ (United States)

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures

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