Barr Laboratories OOS legal decision

The link below is to a nice summary on the legal decision on Barr Laboratories practices with OOS results.

The main finding being that:

Barr’s practice of responding to an out-of-spec result by testing twice more and taking “best two out of three” is insupportable and unscientific, and is not GMP.

http://fdclaw.com/cases/gmp/

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