"Producing medicine" by KATAYAMA SEIYAKUSYO

Audits and Inspections

Manufacturing APIs and intermediates requires inspections by regulatory authorities or audits by customers. Both of our plants have been evaluated highly in inspections by regulatory authorities and in audits by customers.

Hirakata Plant

Organization Period Details
FDA 2008 GMP inspection
2014 GMP inspection
2017 GMP inspection
PMDA 2018 GMP inspection
Prefectural Government 1998 Acquisition of pharmaceutical manufacturer license
2003 Renewal of pharmaceutical manufacturer license
2008 Renewal of pharmaceutical manufacturer license
2013 Renewal of pharmaceutical manufacturer license
Customers authorities 1997- Over 50 audits and over 100 inspections

Toyama Plant

Organization Period Details
FDA 2004 GMP inspection
2016 GMP inspection
EMA/AIFA 2007 GMP inspection
PMDA 2011 GMP inspection
2012 GMP inspection
GMP compliance inspection for export pharmaceuticals
2015 GMP inspection
Prefectural Government 1988 Acquisition of pharmaceutical manufacturer license
1993 Renewal of pharmaceutical manufacturer license
1998 Renewal of pharmaceutical manufacturer license
2002 Renewal of pharmaceutical manufacturer license
2004 GMP compliance inspection for export pharmaceuticals
2007 Renewal of pharmaceutical manufacturer license
2008 GMP inspection
2010 GMP inspection
2012 Renewal of pharmaceutical manufacturer license
Acquisition of veterinary drug manufacturer license
2014 GMP inspection
2017 Renewal of pharmaceutical manufacturer license
Customers authorities 1988- Over 50 audits and over 300 inspections
  • PMDA : Pharmaceuticals and Medical Devices Agency
    FDA : U.S. Food and Drug Administration
    EMA : European Medicines Agency
    AIFA : Agenzia Italiana del Farmaco
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