1259745

Xtreme Tools International, Inc — FEI 3010314796

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
January 31, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Opa Locka, FL (United States)

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
136121 CFR 211.100(a)Absence of Written Procedures
154021 CFR 211.125(a)Strict control not exercised over labeling issued
183321 CFR 211.84(d)(1)Identity Testing of Each Component
356521 CFR 211.58Buildings not maintained in good state of repair
360321 CFR 211.160(b)Scientifically sound laboratory controls