The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of its $12 billion CareFusion acquisition in 2015.
The warning letter, dated Nov. 22 and posted on Dec. 17, involves inspections conducted in May at a former CareFusion facility in San Diego. It notes near the top that BD makes Pyxis medication management systems including the Pyxis MedStation ES, Pyxis ES Anesthesia, and Pyxis MedBank.
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. Four involved cybersecurity vulnerabilities. Of 256 open tickets for server software issues, 55 for thermal effects fell under the catastrophic or severe category. (Read the full FDA warning letter here.)
BD mentioned the warning letter in its recently released annual report, recording a $28 million liability in Q4 related to estimated future costs related to the warning letter.
In its annual report, BD also disclosed that its cybersecurity team recently identified incidents of unauthorized activity related to Pyxis and Parata products. In response, it terminated the unauthorized access and applied additional security measures.
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.
According to BD, Pyxis systems are meant to reduce errors at pharmacies and hospitals when it comes to the dispensing of medications.
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. It’s also paying the SEC $175 million to resolve an investigation into prior public disclosures related to Alaris.
