1149741

The Skin Atelier, Inc. — FEI 3005976760

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 25, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Goshen, NY (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
136121 CFR 211.100(a)Absence of Written Procedures
155021 CFR 211.125(f)Procedures Written and Followed
188321 CFR 211.165(a)Testing and release for distribution
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
431421 CFR 211.84(d)(2)Reports of Analysis (Components)