1240856

The Skin Atelier, Inc. — FEI 3005976760

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 26, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Goshen, NY (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
192621 CFR 211.166(b)Adequate number of batches on stability
363221 CFR 211.170(b)Annual visual exams of drug products