FDA Inspection 1121761 — Front Range Laboratories Inc

Front Range Laboratories Inc — FEI 3003240654

The FDA completed an inspection of Front Range Laboratories Inc on March 20, 2020 in Loveland, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 20, 2020
Fiscal Year
2020
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Loveland, CO (United States)

Citations

IDCFRDescription
127021 CFR 211.68(b)input/output verification
145121 CFR 211.113(b)Procedures for sterile drug products
189021 CFR 211.165(e)Test methods