One of the subsidiaries of the rapidly expanding BTG has temporarily stopped manufacturing some products at a U.S. plant after the FDA cited it in a warning letter.
In an earnings note today, BTG said its Biocompatibles unit had received an FDA warning letter sometime in the last three months for its plant in Oxford, CT. The company said the FDA had problems with its process validations, data analysis, complaint investigations and environmental controls at the facility and it voluntarily halted production of brachytherapy products. According to The Guardian, BTG management has indicated that it believes the problem stems from Biocompatibles needing to catch up to new FDA regulations and that the warning letter is not an indication of a broader problem at the facility.
"We are working to identify and implement processes and procedures to address these concerns," the company said in its statement. BTG said the business had sales of £7.3 million ($11 million) and a pre-tax profit of less than £1 million ($1.5 million) in the 12 months ended March 31.
Biocompatibles also manufacturers drug-coated beads, its largest product line, while brachytherapy products are its smallest line, the company said. BTG picked up the specialty company in 2010 in a $242 million deal as part of its expansion and diversification plan, which has continued. In May the company agreed to pay up to $420 million in two deals to pick up Seattle-based Ekos and the targeted therapies division of Nordion, which also uses radioactive glass beads in a targeted approach to treating liver cancer. It said today it is on schedule to hit more than $1 billion in revenues by 2021. It also said today it expects full-year sales to range from £235 million to £245 million ($356 million to $370 million).
- here's the press release
- read more from The Guardian