FDA Inspection 665652 — Tricorex, Inc

Tricorex, Inc — FEI 1937909

The FDA completed an inspection of Tricorex, Inc on Jun 7, 2010 in Perryville, MO. 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
Jun 7, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Perryville, MO (United States)

Citations

IDCFRDescription
109821 CFR 211.22(c)Approve or reject procedures or specs
122721 CFR 211.67(c)Cleaning/maintenance records not kept
127421 CFR 211.68(a)Calibration/Inspection/Checking not done