FDA Inspection 1037364 — Future Pak LLC

Future Pak LLC — FEI 1824909

The FDA completed an inspection of Future Pak LLC on Jan 11, 2018 in Wixom, MI. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 11, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wixom, MI (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified

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