Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.
PRNewswire - Tuesday September 22, 1998
The agency inspected Epitope's Beaverton, Ore. facility in April, and said that the company had not properly validated its manufacturing processes, and had not ensured that collection devices or confirmatory Western Blot test kits would not be contaminated.
Epitope CEO John Morgan said the company had quickly responded to the FDA's June 22 warning letter, which was made public Tuesday.
"We do not believe any of the observed deficiencies affected the safety or effectiveness of any of our products," said Morgan.
The agency also said Epitope had not ensured that complaints to its distributor, Organon Teknika, were passed on. The FDA said six complaints sent to Organon Teknika between June 1996 and April 1998 on the HIV-1 Western Blot Kit were not forwarded.
Two of those complaints were related to adverse events that might have been associated with the test kits. The FDA found two instances where patients reported small blisters in their mouths where the OraSure collection device had been placed.
These reports appear not to be device-related, said Morgan.
He said this was the company's first inspection under new, stricter, FDA rules. "This is a learning process for the industry," said Morgan. "We are fully supportive of the FDA's regulations and believe our process will help us implement and meet those regulations quickly and to their expectation."
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