The FDA sent warning letters to Baxter (NYSE:BAX) this year, flagging infractions at an Illinois plant where Baxter makes its HomeChoice dialysis device and at a California plant that makes drug infusion pumps.
In a warning letter sent Jan. 17 and posted by the FDA Feb. 10, the watchdog agency flagged 6 violations discovered during inspections last summer of Baxter’s Round Lake, Ill., HomeChoice plant.
Baxter replaced failed components that didn’t meet specs, but never investigated the cause of the failures in the HomeChoice peritoneal dialysis systems, which are expected to last 10 years, according to the letter. It was the 2nd time the FDA flagged Baxter for the infraction, 1st noted during inspections in the spring and summer of 2012, the agency said.
The letter also cited continuing problems with Baxter’s procedures to correct and prevent problems with infusion pumps also made at the plant. Those problems were also 1st observed during inspections in April and June 2012, according to the letter.
The other letter, dated Dec. 19, 2013, and posted Feb. 18 by the agency, also flagged problems with infusion pumps, this time made in a Baxter plant in Irvine, Calif. The FDA cited an unspecified number of complaints of bladder ruptures for the devices, saying that the company’s corrective and preventive systems are inadequate.
CEO Robert Parkinson acknowledged the most recent warning letter during a conference call with analysts last month, saying that Baxter is working with the FDA to remedy the violations.
"We’ve been working to address the FDA’s initial 43 observations, including through a global quality system improvement plan, which we’ve reviewed with the agency and which we’re in the progress of implementing. In light of the letter’s focus, we do not anticipate an impact on product availability for patients," Parkinson said
Christopher Walker contributed to this report.