FDA Inspection 812252 — Quantum Analytics Group Inc.

Quantum Analytics Group Inc. — FEI 3010166238

The FDA completed an inspection of Quantum Analytics Group Inc. on December 28, 2012 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
December 28, 2012
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monmouth Junction, NJ (United States)

Citations

IDCFRDescription
203121 CFR 211.194(a)Complete test data included in records
440621 CFR 211.194(a)(2)Suitability of testing methods verified