Puerto Rico Good Manufacturing Practices

Contact Form - Your First Step

In Puerto Rico, major healthcare fraud is civilly and criminally prosecuted by the United States Attorney’s Office for the District of Puerto Rico, although some cases have been brought by Districts within the mainland United States with special expertise in pharmaceutical fraud False Claims Act violations.

One of the largest healthcare fraud qui tam cases arose from violations of the False Claims Act in a Puerto Rico manufacturing plant due to fraud and non-compliance with the Current Good Manufacturing Practice (CGMP) regulations. The case was resolved in 2010, when GlaxoSmithKline (GSK) agreed to pay the United States a total $750 million to settle the qui tam lawsuit, alleging GSK manufactured and distributed certain adulterated drugs made at GSK’s manufacturing facility in Cidra, Puerto Rico, in violation of the CGMP regulations. Of the $750 million settlement amount, $150 million resolved a criminal fine and the remaining $600 million settled civil FCA charges. This settlement involved charges related to product contamination and dosage irregularities affecting the drugs: Paxil, Avandia, Avandament, Coreg, Bactroban, Abreva, Cimetidine, Compazine, Denavir, Dyazide, Thorazine, Stelazine, Ecotrin, Tagamet, Relafen, Kytril, Factive, Dyrenium, and Albenza. The relator received a $96 million share (22%) of the federal recovery.

As Puerto Rico receives and distributes significant expenditures of Medicare funding, it is frequently targeted by dishonest health care corporations and health care providers. Also, Puerto Rico is home to more than 30 manufacturing facilities and is the 5th leading location for pharmaceutical manufacturing; it is the third largest biotechnology manufacturer and the seventh largest medical device exporter with in excess of 50 plants.