Healthcare company Baxter prides itself on producing lifesaving medical products, including things like IVs, pharmacy devices and software, and renal therapy technologies for dialysis patients. You know, the types of items you trust are developed and manufactured with the utmost care and meticulous attention to detail?
Too bad the U.S. Department of Justice announced a judgement against Baxter last week, requiring the company to pay $18 million for failing to employ good manufacturing practices at a North Carolina facility.
The judgement is to resolve criminal and civil liability relating to sterile products, because apparently the sticklers at the FDA expect that, when you manufacture an IV solution, you should do so in a sterile environment.
Here’s what allegedly happened at Baxter, according to the Justice Department: The company manufactured large-volume sterile IV solutions in a clean room equipped with HEPA filters in the ceiling. When an employee reported finding mold on the filters, production at the Baxter plant just continued on as normal, for months, until a surprise inspection by the FDA ID’d the mold. What’s not clear is whether the FDA was actually tipped off by a Baxter employee, Christopher Wall, who is named in the judgement as a whistleblower, and will receive nearly half a million dollars as part of the civil settlement.
Well, needless to say that post-inspection, the FDA was none too pleased that the mold had proliferated to a level the organization said was too numerous to count.
The good news is that the FDA says “there was no evidence of impact on the IV solutions from the mold found on the filters.” A Baxter spokeswoman told Reuters that the company terminated several members of the facility’s management team in response to mold incident, and are enhancing the training and compliance processes for employees throughout the facility to ensure it doesn’t happen again.