Date: Mar 14, 2019
Keller and Heckman Partner Rick Stearns was quoted in an article on quality control issues that the U.S. Food and Drug Administration (FDA) identified at a drug manufacturing plant in Jayuya, PR owned by Baxter Healthcare Corporation. According to the article, that appeared in the March 14, 2019 issue of The Capitol Forum, an FDA investigation found that that quality assurance team at Baxter failed to properly evaluate quality flaws and that the company did not keep some of its building in a good state of repair.
The Capitol Forum obtained the information about Baxter from a Form 483 that it obtained through a FOIA request submitted to FDA. (Information on FDA’s Form 483 can be found on the Agency’s website.) The publication interviewed Mr. Stearns about FDA’s findings. Noting that FDA identified quite a number of issues that seem to be fairly significant, Mr. Stearns stated, “I certainly would not be surprised if a Warning Latter followed from this, given the fact that there have been similar issues previously identified at this facility. It really depends on the response that Baxter has submitted and how satisfied FDA is with that response.”