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BTG Facility Still Being Assessed After FDA Warning Letter

By Dan Stanton , 17-Jul-2013
Last updated the 17-Jul-2013 at 13:12 GMT

BTG has confirmed it halted production at the US brachytherapy device manufacturing plant that was hit with a US FDA warning letter in April.

Operations at the Oxford, Connecticut facility stopped in the first week of May, but BTG only provided details of the temporary measure during an interim management meeting held yesterday at its headquarters in London, UK.

Company director of investor relations Andy Burrows told in-Pharmatechnologist.com BTG is one of five suppliers of brachytherapy devices - which are implantable radiotherapy devices used to treat cancer – and suggested that this should prevent shortages airing from the production disruption.

“Any orders that came in we either directed them to our sources or to other manufacturers. We would have thought twice about stopping production if there hadn’t been any alternative supply.”

Burrows said the site - which was acquired as part of the £177m ($269m) purchase of Biocompatibles in 2010   - “hadn’t been inspected since about 2006,” and was therefore not up-to-date with requirements, validations and expectations which evolve over time.

Awaiting Assessment

In the warning letter the US Food and Drug Administration (FDA) identified a number of procedures, documentation and quality systems that were not up to code as well as issues relating to BTG’s investigation of two customer complaints.

“Though these weren’t trivial things, there was no suggestion of any harm to patients,” said Burrows.

He added that BTG took the decision to halt production until a full assessment had been completed. This is still ongoing and no timescale for manufacturing restart has been announced.

As one of the smallest part of BTG’s operations, the brachytherapy business generated revenues of £7.3m and a profit before tax of less than £1m, according to a company statement .

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