1153243

Premier Trends LLC — FEI 3014373428

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 29, 2021
Fiscal Year
2021
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Monroe Twp, NJ (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
188321 CFR 211.165(a)Testing and release for distribution
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements