1102635

Derma Care Research Labs LLC — FEI 3013570706

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 24, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Daytona Beach, FL (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
189121 CFR 211.165(f)Failing drug products not rejected
360321 CFR 211.160(b)Scientifically sound laboratory controls