FDA Inspection 1044948 — Englewood Lab, Inc

Englewood Lab, Inc — FEI 3013020160

The FDA completed an inspection of Englewood Lab, Inc on March 19, 2018 in Totowa, NJ. 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 19, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Totowa, NJ (United States)

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed