FDA Inspection 735402 — VLV Associates, Inc.

VLV Associates, Inc. — FEI 2245539

The FDA completed an inspection of VLV Associates, Inc. on July 14, 2011 in Whippany, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
July 14, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Whippany, NJ (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures
323321 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
53921 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
54121 CFR 820.70(c)Environmental control Lack of or inadequate procedures