FDA 483 - Sumitomo Dainippon Pharma Co., Ltd. - November 22, 2019

An FDA inspection of Sumitomo Dainippon Pharma Co., Ltd. in Mie Prefecture, Japan, revealed significant deficiencies in equipment cleaning and maintenance. Inspectors found a shared piece of equipment, untouched since 2007, contained unknown product residue and lacked cleaning records. The firm also failed to include critical equipment in its cleaning validation studies and lacked adequate written cleaning procedures.