FDA MAY HALT IMPORTS OF IBT DEVICES DUE TO MANUFACTURING VIOLATIONS
International Brachytherapy (IBt) violated enough current good manufacturing practices (cGMPs) that the FDA may prohibit the firm from shipping its devices into the U.S. until the problems are fixed, the agency said in a warning letter.
The FDA inspected an IBt facility in Belgium July 3 to 6. The products cited in the Oct. 11 letter were iodine 125 and palladium radioisotope brachytherapy devices.
Due to the number and severity of the violations, the FDA warned it could use "detention without physical examination," barring the importation of the company's products until the problems have been fixed.
According to the warning letter, IBt did not:
Properly verify results from tests and processes;
Verify that the same materials were used in different tests;
Have documented plans to fix and prevent quality problems;
Maintain complaint files or show that complaints were reviewed and investigated;
Keep records of device changes and process deviations;
Identify training needs;
Document procedures to ensure all personnel were properly trained;
Alter standard operating procedure documents when procedures changed; or
Document how to determine if a device-related death, serious injury or malfunction was reportable.
The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6054d.pdf (http://www.fda.gov/foi/warning_letters/g6054d.pdf).