International Brachytherapy Removed From FDA Import Alert List

International Brachytherapy announced its products are no longer on the FDA’s import alert list after the agency said it responded adequately to observations in a 2006 warning letter.

The letter had cited the radiotherapy implant maker for violating enough current good manufacturing practices that the FDA was considering prohibiting the firm from shipping its devices into the U.S. until the company fixed the problems.

Although a company representative had responded to the FDA investigator’s observations during the 2006 inspection, all but one of the explanations were inadequate, the warning letter noted.

The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6054d.pdf.