1023315

Exact-Rx Inc — FEI 3004000544

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
August 29, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Melville, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
1002221 CFR 310.305(a)Failure to develop written procedures
673021 CFR 314.80(b)Failure to develop written procedures