FDA Halts Import of Ansell Condoms After Failed Safety Test

Daily Reproductive Health Report

Contraception & Family Planning | FDA Halts Import of Ansell Condoms After Failed Safety Test
[Sep 20, 2005]

FDA on Friday barred the import of condoms made in Ansell's Surat Thani facility in Thailand after the product failed to meet the agency's safety standards, the Sydney Morning Herald reports. FDA placed Ansell's condoms on Level 2 restrictions -- meaning the condoms will have to pass agency tests in at least 10 successive shipments before the restriction is removed -- after an undisclosed failure during the testing of two shipments. If any future shipments do not meet agency standards, the company will be required to recertify the facility (Freed, Sydney Morning Herald, 9/17). "It's a concern for the company, and they are working with the FDA to work through the problems as quickly as possible," an unnamed Ansell spokesperson said (Leyden, Herald Sun, 9/17). Ansell -- which produces the condom brand names LifeStyles, Mates and Kama Sutra -- is the third-largest condom seller in the world, and the U.S. is its largest market for the products (Sydney Morning Herald, 9/17).