1165260

Eco Lips, Inc. — FEI 3004966182

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 24, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Cedar Rapids, IA (United States)

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
136121 CFR 211.100(a)Absence of Written Procedures
191421 CFR 211.166(a)Lack of written stability program
192621 CFR 211.166(b)Adequate number of batches on stability
194221 CFR 211.180(e)Records reviewed annually
440221 CFR 211.192Written record of investigation incomplete