FDA Warns CR Bard About Puerto Rico Plant

US regulators have told medical device maker C.R. Bard Inc to correct manufacturing problems uncovered during an inspection of a plant in Puerto Rico, a letter released by the FDA said.

FDA inspectors who visited the plant from November 2007 through February 2008 found practices that were “not in conformity” with federal manufacturing standards, a July 22 letter from the FDA said.

Devices made at the plant in Humacao, Puerto Rico, include the Kugel Hernia Patch and the Vacora Biopsy Probe, the letter said. The warning letter is available on the FDA web site at http://www.fda.gov/foi/warning_letters/s6944c.pdf.

C.R. Bard spokeswoman Holly Glass said the company had disclosed the letter July 28 in a quarterly filing with the Securities and Exchange Commission. In that filing, the company said it “intends to fully implement corrective actions to address the concerns identified.”

SOURCE: Reuters