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Baxter Receives Nine 483 Observations

September 16, 2009
An inspection of Baxter Healthcare led to nine Form 483 observations, including a citation for conducting quality-related activities as projects outside the quality system. Projects that were not tracked or monitored within the quality system included investigations into potential causes of low yield or low purity for the Isolex product, the FDA found during an April inspection of the Deerfield, Ill., facility. “Baxter has responded to the FDA with appropriate actions to correct the issues addressed in the 483 observations,” Christopher Bona, director of global bioscience communications at Baxter, said.
The GMP Letter