1274882

CosMedical Technologies, LLC — FEI 3007481323

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
July 7, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Davie, FL (United States)

Citations

IDCFRDescription
107921 CFR 211.22(a)Contract drug products--lack of responsibility
110521 CFR 211.22(d)Procedures not in writing, fully followed
149621 CFR 211.122(a)Sampling/testing of labeling/packaging materials
188321 CFR 211.165(a)Testing and release for distribution
191421 CFR 211.166(a)Lack of written stability program
241921 CFR 211.198(a)Complaint Handling Procedure