986769

Cosmaceutical Research Lab Inc. — FEI 3003878590

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 23, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Surrey (Canada)

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
126321 CFR 211.68(b)Computer control of master formula records
150521 CFR 211.122(d)Label storage access limited to authorized personnel
197521 CFR 211.182Written records kept in individual logs
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls