BD
(NYSE: BDX)
continues to grapple with problems related to technology it brought over from its $12 billion acquisition of CareFusion nearly a decade ago.
Our Drug Delivery Business News sibling site reports that BD recently received an FDA warning letter over a May inspection of a former CareFusion facility in San Diego. The warning letter is related to Pyxis automated medication dispensing systems.
The inspection found a failure to establish appropriate quality systems and follow rules related to reporting problems and issuing product corrections and removals. For example, the warning letter mentions 544 open tickets for software defects, of which 111 were categorized as catastrophic or severe.
In a statement shared by a spokesperson with Drug Delivery Business News, BD said:
Ensuring the safety, quality and the regulatory compliance of our products is our top priority at BD. Following an FDA inspection in May of our Medication Management Solutions site in San Diego, we took immediate action that we believed would fully address the FDA’s observations. We have responded to the recent FDA letter within the agreed upon timeline and have emphasized that BD takes these matters very seriously and is acting with urgency. We are fully cooperating with the FDA on this matter.
The warning letter comes as BD moves beyond previous problems related to its Alaris infusion pump systems, another technology that came over through the acquisition of San Diego–based CareFusion. BD resumed U.S. Alaris distribution after receiving updated FDA clearance in July.
