Lab owner and firm sentenced for violations - Quality Research Labs, Inc

The president of a small food and drug testing laboratory near Newark, N.J., was sentenced to one year's probation and fined $18,800 for failing to give FDA investigators complete and accurate information during an inspection of his laboratory.

Judge Alfred Lechner Jr., of the U.S. District Court for the District of New Jersey, sentenced Paul Feldman, owner and president of Quality Research Labs, Inc. (QRL), Whippany, N.J., on May 9, 1994. Feldman must also perform 200 hours of community service and is prohibited for a year from performing virtually any work in areas involving FDA-regulated products.

In addition, Judge Lechner sentenced QRL to one year's probation, imposed similar work restrictions, and fined the company $7,500 for causing shipment of drugs adulterated because of good manufacturing practice violations.

Feldman and the company had pleaded guilty to the charges in January.

Feldman's violations came to light in 1989 after a New Jersey generic drugs manufacturer for which QRL worked under contract to test drugs suspected a manufacturing error in a prescription vitamin drug for children. The firm had inadvertently used the wrong source of vitamin D raw material in some lots of the product, causing the vitamins to contain up to 40 or 50 times the amount of vitamin D indicated on the label.

When the company discovered the error, it initiated a class I recall, and FDA issued a press release warning parents not to give children the product. Letters were sent to pharmacists, dentists and physicians, asking that customers and patients be notified to return the product.

As a follow-up to the recall, FDA inspected QRL, which had been responsible for testing the vitamin D raw material and the finished tablets for the manufacturer. Newark district investigators Barbara Schultz, Meyer Slobotsky, and Henry Avallone inspected QRL on June 2, 5, 9, 12, 14, 21, and 22.

"The investigators' assignment was to examine the vitamin D situation, but also to see if the problem extended to other products and other types of testing," says compliance officer Bill Berbaum. "They looked at the microbiological testing and--like we always do--tried to verify the company had the equipment and supplies needed to do its testing. One thing you need for the microbiological testing Feldman claimed to do is growth promotion media. The investigators looked around and didn't see any."

When asked about this, according to the investigators, Feldman said he had just run out of media and ordered more. He gave them the names of four suppliers he claimed were his sources for the media. When asked to produce the invoices to document media purchases, Feldman said he didn't have them because he throws out invoices on the advice of his accountant. After more questioning, he claimed to have proof of the purchases in his checkbook ledger, but when the investigators asked to see the ledger, Feldman wouldn't show it to them.

The investigators visited each of the four media suppliers and learned that none had sold him media since 1987.

On June 21, Schultz and Slobotsky returned to QRL and Feldman showed them a shipment of media that had just arrived. He signed a statement saying he performed microbiological tests using media and then had "just" run out.

The investigators then confronted Feldman with what they had learned from the four suppliers and told him they believed he wasn't doing the tests. Feldman denied this and claimed he was going to have a heart attack. The investigators waited until Feldman appeared composed and then left for the day.

When Schultz and Slobotsky came back the next day, Feldman said he did the microbiological testing with media he bought from a "black market source"--that the media "fell off a truck." He wouldn't identify the source.

Finally, given another opportunity to explain how he did the microbiological tests, Feldman admitted that instead of doing the required tests, he simply incubated the product in the original container for a week, examined the container for swelling, and then guessed at the number of organisms.

During 1988 and 1989, QRL sent approximately 300 such microbiological test reports to one of its clients--a New York food supplement manufacturer.

In August 1990, FDA asked the Department of Justice to initiate a grand jury investigation of Quality Research Labs, Inc., and Paul Feldman. Berbaum and Jacques Maravic, now with FDA's Office of Criminal Investigation, worked with the agency's Office of the General Counsel and the U.S. Attorney's Office. They gathered evidence from boxes of records and dozens of witness interviews with former QRL employees and clients. FDA microbiologist Dennis Guilfoyle, of the agency's New York Regional Laboratory, served as the government expert.

A grand jury indicted Feldman Oct. 20, 1993.

FDA received no reports of injuries attributed to the products QRL was supposed to test.

COPYRIGHT 1994 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group