Successful ANVISA Inspection at Fermion's API plant in Oulu, Finland
Fermion passed successfully ANVISA Inspection 2016 with three minor recommendations.
The Audit was carried out on 1st - 3rd February, 2016 in Fermion's Oulu Plant. The inspection focused on general GMP covering Quality Systems, Equipment and Facilities, Materials, Production, Packaging and Labeling and Laboratroy controls. The Quality System and Manufacturing Facilities were reviewed and as commented by the Inspector in the summary meeting: 'You have a very good Quality System, we have rarely seen such systematic procedures'. We are expecting the final report within two months.