1034097

Paramesh Banerji Life Sciences, LLC — FEI 3011020725

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 7, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
North Brunswick, NJ (United States)

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
113621 CFR 211.25(c)Inadequate number of personnel
136121 CFR 211.100(a)Absence of Written Procedures
144821 CFR 211.111Establishment of time limitations
192821 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability
359221 CFR 211.110(c)In-process materials characteristics testing