FDA Inspection 662720 — SC Johnson Professional USA, Inc.

SC Johnson Professional USA, Inc. — FEI 3001606885

The FDA completed an inspection of SC Johnson Professional USA, Inc. on April 26, 2010 in Stanley, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Stanley, NC (United States)

Citations

IDCFRDescription
135821 CFR 211.100(b)SOPs not followed / documented
189121 CFR 211.165(f)Failing drug products not rejected
363221 CFR 211.170(b)Annual visual exams of drug products
441021 CFR 211.194(a)(5)Calculations performed are in the records