Pfizer’s failure to report the presence of hazardous substances at its Barcoloneta, Puerto Rico drug manufacturing facility will cost the company $190,000 in fines, according to an article from In-PharmaTechnologist.com. In 2014, U.S. Environmental Protection Agency inspectors reportedly found that Pfizer was in violation of the Clean Air Act by not disclosing that it had ammonia and methylamine in amounts above the regulatory limit.
Since the inspection, the hazardous chemicals are no longer used in processes at the facility in amounts above the legal limit and the plant appears now to be compliant, according to the article. Ammonia and methylamine are reportedly used in pharmaceutical production and companies who use them are required to disclose the fact and to have a hazard assessment plan in place.
Read the entire article here.
