Sourcing, Labeling Issues Lead to Baxter Warning Letter

Baxter Healthcare is working its way through a list of compliance problems, ranging from sourcing to quality system issues, included in an FDA warning letter.

The letter, and the April inspection it’s based on, stem from Baxter voluntarily notifying the FDA in March that its Deerfield, Ill., plant had found a sourcing problem with the Dynabeads used with its Isolex reagent kit, Baxter spokeswoman Mavis Prall said. The sourcing problem bled into other issues, which also were noted during subsequent inspections at facilities in California and Germany, she added.

The Sept. 10 warning letter, posted to the FDA website last month, claims the label for the company’s Class III Isolex, a cancer therapy, is false and misleading because the supplier used EU-sourced plasma instead of the U.S.-sourced plasma indicated on the label. Baxter has corrected all the labeling issues, and no adverse events were reported because of the labeling, Prall said.
The GMP Letter