FDA Inspection 698928 — Quantum Analytics Group Inc.

Quantum Analytics Group Inc. — FEI 3010166238

The FDA completed an inspection of Quantum Analytics Group Inc. on November 24, 2010 in Monmouth Junction, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 24, 2010
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monmouth Junction, NJ (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
189021 CFR 211.165(e)Test methods