FDA Inspection 961743 — Nelson Laboratories, LLC

Nelson Laboratories, LLC — FEI 3000717698

The FDA completed an inspection of Nelson Laboratories, LLC on March 11, 2016 in Itasca, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 11, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Itasca, IL (United States)

Citations

IDCFRDescription
360321 CFR 211.160(b)Scientifically sound laboratory controls