626811

Tec Laboratories, Inc. — FEI 3021059

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
October 30, 2009
Fiscal Year
2010
Product Type
Drugs
Project Area
Unapproved and Misbranded Drugs
Location
Albany, OR (United States)

Citations

IDCFRDescription
119421 CFR 211.42(c)Defined areas of adequate size for operations
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
135821 CFR 211.100(b)SOPs not followed / documented
355721 CFR 211.52Washing and toilet facilities are deficient