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FDA hits BMS with warning on GMP violations at Puerto Rico plant

This article was originally published in Scrip

Executive Summary

The US FDA has hit Bristol-Myers Squibb with a warning letter for "significant violations" of good manufacturing practices at its plant in Manati, Puerto Rico, including problems related to inadequate aseptic conditions. The regulator found similar problems at the facility during inspections in 2005 and 2009.

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