The FDA began inspecting manufacturing plants and warehouses after sending
a letter April 7 to all U.S. condom suppliers urging them to be
"particularly vigilant" in quality assurance in view of the "urgency"
posed by the AIDS epidemic and sexually transmitted disease fears.
In testing done between early April and Aug. 10, the FDA said, 41 of 204
sample batches of condoms were "violative" of minimum government
standards.
Eleven of 106 American-made condom batches flunked, along with 30 of 98
imported ones, in a test that consisted of filling a condom with water and
examining it for leaks. A total of almost 51,000 condoms was tested, and a
batch failed if four or more condoms in it leaked.
The agency could not say how many individual condoms failed, but the
inspection design indicated a minimum failure of about one condom out of
every 50.