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About us

Inspections

Global regulatory expertise

Vetter works with you through all phases of regulatory submission. We have an excellent track record with global regulatory agencies, including FDA, EMA, PMDA (Japan), and RP (Germany). Vetter undergoes about 10-15 inspections by different international regulatory authorities and 30-40 customer audits each year. We have successfully completed approx. 50 FDA client products (drug products and diluents) approvals.
 

Inspections from 2014 to 2018 

  • FDA USA: 10 Inspections
  • ​Germany Regierungspräsidium Tübingen (local authority): 8 Inspections
  • COFEPRIS Mexico: 6 Inspections
  • Turkey Ministry of Health: 4 Inspections
  • Russia Centre of Quality Control: 3 Inspections
  • Kazakhstan Kazakh Authority: 3 Inspections
  • South Korea MFDS (formerly KFDA): 2 Inspections
  • FDA Taiwan: 2 Inspections
  • Belarus Ministry of Health: 2 Inspections
  • Brazil ANVISA: 1 Inspection
  • Health Canada: 1 Inspection
  • China CFDA: 1Inspection
  • Saudi Arabia: 1 Inspection
  • Nigeria NAFDAC: 1 Inspection