FDA Inspection 817793 — Chromak Research Inc

Chromak Research Inc — FEI 1000208903

The FDA completed an inspection of Chromak Research Inc on Jan 31, 2013 in Metuchen, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 31, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Metuchen, NJ (United States)

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
181021 CFR 211.160(a)Lab controls established, including changes
189021 CFR 211.165(e)Test methods