Baxter Healthcare has received a warning letter posted by the FDA to its website yesterday, some five months after it issued the warning to the company, and just two weeks shy of the one-year anniversary of the inspections*. The tardiness of the posting is in sharp contrast to the speed of recent inspection-to-posting times, in line with the regulator's stated objective of becoming timelier in issuing its regulatory actions.
The warning relates to two Baxter facilities in Puerto Rico--one in Jayuya, for a case of product discoloration; the other in Guayama, for failing to follow up on consumer complaints of the discoloration.
In Jayuya, the company traced the product discoloration to an equipment malfunction, but it then neglected to "address the possibility of carryover of solution due to the equipment malfunction." Nor did the Baxter extend its investigations to other lots that used the same filling line, risking cross-contamination in 17 product lots.
Baxter had also stated to inspectors that healthcare professionals would identify the discoloration and not use the drug. "It is unacceptable to rely upon the health care professional to fulfill your Quality Control Unit responsibilities," the letter says. "This is a repeat observation from the March 2008 inspection."
Both the Jayuya and Guayama facilities fell down on reporting product defects to the FDA, the agency maintains. Inspectors found 43 consumer complaints concerning discoloration of an amino acid injection--varying from dark yellow to dark brown--dating to February 2010. Yet no report was filed with the FDA. And despite receiving some 40 complaints regarding particle contamination in another product, which initiated a health hazard assessment, Baxter neglected to file a field report.
- see Warning Letter 11-SJN-WL-04
Editor's Note: The Warning Letter mentioned in this article, posted earlier this week on the FDA website, appears to be a re-posting of the letter from earlier this year.