FDA faults Japan­ese man­u­fac­tur­er with da­ta breach, con­t­a­m­i­nat­ed in­jecta­bles

The FDA has come down hard on a Japan­ese man­u­fac­tur­er, with cGMP fail­ures that in­clude batch dis­crep­an­cies left with­out in­ves­ti­ga­tion, da­ta breach­es left un­ad­dressed and the ma­nip­u­la­tion of con­tact plate mea­sure­ments.

Toy­obo Co. re­ceived a warn­ing let­ter on Aug. 19. If it can­not cor­rect the vi­o­la­tions, the FDA can refuse the im­port of drugs man­u­fac­tured at the Shi­ga site in­to the US. Toy­obo has 15 days to re­spond to the let­ter.

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