EPA fines Pfizer pharma plant in Puerto Rico for chemical info fail

The U.S. Environmental Protection Agency fined Pfizer $190,000 for failing to disclose chemical information at its Barceloneta facility in Puerto Rico.

The fine stems from a 2014 inspection of the plant that found it was in violation of the federal Clean Air Act’s chemical accident prevention, chemical safety, and risk management requirements, the agency said in a release.

Inspectors discovered regulated substances, including ammonia and methylamine, were present at the facility in amounts higher than what is allowed and were being used without disclosure to the EPA.


Survey: The Critical Role of Innovation in Launching Successful OTC Products

This research aims to understand the importance of product innovation and dose forms in driving new product design and development, consumer engagement and purchase interest for Over-the-Counter medicines. The first 50 qualified respondents will receive a $5 Amazon gift card. Take the survey now.

Liquid ammonia and methylamine gas, which is a derivative of ammonia, is used in the production of some pharmaceuticals. Ammonia is a corrosive that causes severe irritation of the eyes, respiratory tract and skin.

“Emergency responders need to know where hazardous chemicals are used and stored as well as how to deal with any risks associated with those chemicals,” Carmen Guerrero Pérez, the director of the EPA’s Caribbean division, said in a statement.

Pfizer took action following the inspection and the regulated substances are no longer used at the facility in amounts above the regulatory limit. The plant “now appears to be in compliance,” the agency said.

Part of the Clean Air Act requires companies to develop plans for informing the public and local response agencies should an accidental release occur.

After Pfizer's blockbuster drug Lipitor came off-patent and revenue began to lag, the company announced in 2013 it planned to close the Barceloneta plant by 2017.

Related Article:
Pfizer to close Puerto Rico plant


Suggested Articles

Neopharma, which has been buying and building plants for several years, is buying a sterile injectables plant and assets in Japan from India’s Lupin. 

Already knocked by the FDA four times this year, Dr. Reddy’s now has a fifth Form 483 to dwell on. This time it’s at a plant with a history of faults.

In a warning letter, the FDA details how a Chinese OTC drugmaker handed over documents faked just for the agency's inspection—and admitted it.