646066

Vertical Pharmaceuticals, LLC — FEI 3004421212

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
February 24, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Sayreville, NJ (United States)

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
194321 CFR 211.180(e)(1)Review of representative number of batches
356221 CFR 211.56(c)Written procedures lacking for use of pesticides etc.
357021 CFR 211.100(a)Approval and review of procedures
434021 CFR 211.142Written warehousing procedures established/followed
900121 CFR 211.22(a)Lack of quality control unit