The US FDA has warned Bristol-Myers Squibb (B-MS) about significant GMP violations at plant in Manati, Puerto Rico, including a failure to establish anti-contamination protocols.
In a letter published on its website, the agency said B-MS has not implemented “scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity.”
The warning follows a March inspection of the plant where B-MS makes, among other products, the rheumatoid arthritis drug Orencia and the blood clot buster Coumadin.
The Food and Drug Administration (FDA) also said that similar problems were found at the facility during inspections in 2005 and in 2009. In response, B-MS said it has already begun correct the problems.