FDA Inspection 820882 — Qualimax LLC

Qualimax LLC — FEI 3004599007

The FDA completed an inspection of Qualimax LLC on Mar 6, 2013 in Ridgefield, 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). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 6, 2013
Fiscal Year
2013
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Ridgefield, NJ (United States)

Citations

IDCFRDescription
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action