FDA Inspection 681412 — Quality Chemical Laboratories

Quality Chemical Laboratories — FEI 3002323490

The FDA completed an inspection of Quality Chemical Laboratories on August 24, 2010 in Wilmington, NC. 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
August 24, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Wilmington, NC (United States)

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
189021 CFR 211.165(e)Test methods
203421 CFR 211.194(d)Laboratory equipment calibration records