1.Please detail the procure for filing new product for USA market.
2.Filing procure for USFDA inspection /Audit for existing and new product
For filing of new generic product (ANDA), please refer to USFDA guidelines from their website. It is a long and elaborate procedure.
USFDA inspection is triggered after your ANDA application is submitted to USFDA authorities and when your ANDA is taken for review by them.