The perils of outsourcing: Takeda Pharmaceuticals has filed suit in Japan against a CMO, Taiyo Pharmaceuticals, for damages resulting from the recall of several lots of the antibiotic Pansporin following two occasions in which commingling glass was found in injectible vials. The incidences occurred in May and June of this year.
Takeda claims that Taiyo failed to implement sufficient quality control measures, and that it also failed to maintain adequate production records that might have more clearly identified the range of possible suspect product. Damages have been estimated at 2.8 billion yen.
Not surprisingly, Takeda has decided to bring the manufacturing of Pansporin back in-house for the time being.
--PWT
