The Los Angeles Times - Friday, July 7, 2000
David Hermann

In Washington, FDA spokeswoman Sharon Snider said Cal-Test Diagnostics Inc. and its president, Horng Liang "Robert" Chen, were not keeping adequate records about where and to whom the kits were being sold.

That violation of FDA rules, she said, coupled with complaints about the reliability of some of Cal-Test's products, initiated an FDA investigation that led to U.S. District Court.

"Basically, the main problem was that with the exception of three pregnancy test kits, none of their other products were approved -- they were marketing unapproved test kits," Snider said Thursday. "That's a violation of the Food, Drug and Cosmetic Act."

Chen's Ontario-based attorney, Robert Spitz, says his client didn't do anything wrong, but will abide by the court's ruling.

Spitz, Chen, FDA officials and a federal judge signed a consent decree on June 19 stipulating that the company would stop selling its diagnostic kits and under FDA supervision, destroy any kits it has already produced.

Laurel Eu, a public affairs specialist with the FDA's Irvine office, said employees there are still working with Cal-Test representatives to schedule a date when the destruction of the company's existing stock will take place.

Under the terms of the decree, Cal-Test will be allowed to resume operations once the FDA and an independent expert hired by Cal-Test are satisfied that the company is in compliance with the law.

Spitz said because Cal-Test never conducted the tests the FDA requires to approve such diagnostic kits, the FDA is unfairly assuming that the kits are substandard.

"There was nothing wrong with [the kits]," Spitz said. "My client has indicated that he will probably move the business overseas or to Mexico where there aren't so many restrictions."

Much of Cal-Test's business appears to have been international. One of the company's HIV test kits is listed by the World Health Organization on its Internet Web site as a test evaluated by the Geneva, Switzerland-based organization and which meets its criteria.

The organization's site goes on to caution, however, that its evaluation does not constitute an approval or license of the kit and that the responsibility for licensing, "lies with the regulatory authorities in each country," such as the FDA.

Richard LeClair, deputy director of the World Health Organization's office at the United Nations in New York, said that the data on the Web site were intended to provide information for member governments and was not a list of the organization's endorsed products.

"We don't distribute any products ourselves," he said.

The FDA took Cal-Test to court earlier this year after more than four years of problems with the company that included an FDA citation for violations in 1996 and a warning letter sent to Chen in 1997.

When those actions occurred, the company was located in two offices in an industrial complex on Roswell Avenue in Chino. It has since moved to a small industrial building at 5482 Arrow Highway in Montclair.

On Thursday, Chen was approached in the parking lot outside the building just after 5 p.m. and reluctantly spoke about the difficulty he will have complying with FDA requirements that he hire an outside expert to evaluate Cal-Test's compliance with the law.

"If we correct it the way they want it, it takes too much money," he said, adding that he will probably move the business to China or Mexico. "It's basically impossible to continue business [here]," he said. Chen refused to reveal where the company sells its kits, except to say that all of the distribution business was outside of the U.S.

He also declined to say how many people his business employs and if the court's decision meant that they could lose their jobs.

Ron Tesarski owns the building that Chen is leasing.

Tesarski said after Cal-Test moved into the building in January, it appeared to be busiest in February and March with as many as 10 employees coming and going throughout each weekday.

The potential closure of the business will most likely not have a significant economic impact on Montclair, according to officials in Chino who were not even aware that the business had relocated.

Chino's director of redevelopment said that Cal-Test was not a sales tax-producing business and City Manager Glen Rojas said the only potential losses to the city were several jobs and a small amount of property tax revenue.

Tesarski said the potential departure of Cal-Test and Chen will not hurt the landlord's bottom line, either.

"He's on a year lease," Tesarski said. "I'm not concerned about that."
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