720401

Cosway Company, Inc. — FEI 3000205953

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Carson, CA (United States)

Citations

IDCFRDescription
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
176721 CFR 211.137(a)Expiration date lacking
188621 CFR 211.165(c)Sampling and testing plans not described
191221 CFR 211.166(a)Written program not followed
195721 CFR 211.180(e)(2)Review of problem drugs
202721 CFR 211.192Investigations of discrepancies, failures
261921 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved