FDA Inspection 1083917 — Biochem Laboratory, Inc.

Biochem Laboratory, Inc. — FEI 3005094136

The FDA completed an inspection of Biochem Laboratory, Inc. on March 26, 2019 in Lyndhurst, 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 26, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lyndhurst, NJ (United States)

Citations

IDCFRDescription
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs