983015

Soaptronic LLC — FEI 2027600

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 23, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Lake Forest, CA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
113321 CFR 211.25(a)GMP Training Frequency
135821 CFR 211.100(b)SOPs not followed / documented
360321 CFR 211.160(b)Scientifically sound laboratory controls