1062302

Medical Chemical Corporation — FEI 2013736

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 16, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Torrance, CA (United States)

Citations

IDCFRDescription
103321 CFR 211.22(a)Authority lacking to review records, investigate errors
111121 CFR 211.25(a)Training , Education , Experience overall
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
154021 CFR 211.125(a)Strict control not exercised over labeling issued
178721 CFR 211.80(a)Procedures To Be in Writing
191221 CFR 211.166(a)Written program not followed
360321 CFR 211.160(b)Scientifically sound laboratory controls