Inspections

Our excellent track record with global regulatory agencies

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 inspections by different international regulatory authorities and over 50 customer audits each year. We have successfully completed approx. 130+ FDA and EMA client products (drug products and diluents) approvals.

Inspections

Successfully passed inspections ​over the last 10 years

24
FDA USA
15
​Germany Regierungspräsidium Tübingen (local authority)
12
South Korea MFDS (formerly KFDA)
1
FDA Taiwan
  • Japan PMDA: Mutual Recognition Agreement / Paper-based inspection
  • COFEPRIS Mexico: 8 inspections
  • Turkey Ministry of Health: 6 inspections
  • Russia Centre of Quality Control: 12 inspections
  • Austria AGES: 3 inspections
  • Belarus: 2 inspections
  • Kazakhstan Kazakh Authority: 2 inspections
  • EUAU: 6 inspections
  • Brazil ANVISA: 2 inspections
  • Health Canada: Mutual Recognition Agreement
  • China NMPA: 3 inspections
  • Libya: 2 inspections

Other authorities visited Vetter before 2016, including those from Algeria and Saudi Arabia.