U.S. Attorney Carmen Ortiz on Tuesday announced that GlaxoSmithKline has agreed to settle civil and criminal charges related to the subsidiary in Puerto Rico.
Ortiz said the London-based company will pay $150 million in criminal fines and $600 million in civil penalties.
The criminal complaint alleges that SB Pharmco, the GlaxoSmithKline subsidiary in Puerto Rico, didn't ensure that finished products were free from microorganisms. It also accuses the company of producing Paxil products that split - and didn't give patients enough of the medicine or have a time-release mechanism.
The drug Avandamet, a Type II diabetes drug, didn't always have an FDA-approved mix of active ingredients, and could sometimes have too much or too little to have a therapeutic effect. The complaint also alleged the plant had a history of product mix-ups, including drugs of different types and strengths to be mixed within the same bottle.
In 2005, GlaxoSmithKline agreed to fix deficiencies at its now-closed plant in Cidra, Puerto Rico,that allowed tablets of Paxil to split apart before reaching consumers.