FDA Inspection 1046665 — Xttrium Laboratories, Inc.

Xttrium Laboratories, Inc. — FEI 3008436464

The FDA completed an inspection of Xttrium Laboratories, Inc. on March 15, 2018 in Mount Prospect, 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 15, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Mount Prospect, IL (United States)

Citations

IDCFRDescription
145021 CFR 211.113(a)Procedures for non-sterile drug products