Investigators' Reports

Illegal Use of Vet Drug Results in Fines, Probation

by Dixie Farley

Investigation by FDA agents in Missouri and New York led last fall to fines and probation for one man and deferred prosecution for another on charges of prescription drug misbranding and product tampering.

On Sept. 8, 1995, the U.S. District Court for the Eastern District of Missouri, St. Louis, fined Joseph Schilling, 31, of St. Louis, $1,000 with $25 special assessment, and sentenced him to three years' probation with mandatory drug testing. Schilling had pleaded guilty to drug misbranding caused by dispensing a prescription drug without a license.

On Oct. 17, 1995, the U.S. District Court for the Southern District of New York, New York City, accepted Dean Gabriel, 25, of New York City, into a six-months deferred prosecution program. Gabriel was charged with product tampering.

Following a tip from an informant, St. Louis police began surveillance of Schilling on Feb. 11, 1994, arresting him sometime after midnight on suspicion of possessing a narcotic and marijuana. In Schilling's apartment, the police seized drug paraphernalia and vials of suspected Ketaset (ketamine), a veterinary anesthethic. Schilling cooperated with the police and named Gabriel as his source.

Because FDA regulates Ketaset as a veterinary drug and the drug is not a controlled substance regulated by the Drug Enforcement Administration, the police notified the agency's Kansas City Office of Criminal Investigations (OCI), which in turn notified OCI agents in the New York field office, Jersey City, N.J. In deference to probable federal charges, the local charges were held in abeyance.

Kansas City agents began investigating Schilling, and New York agents investigated Gabriel with surveillance, examination of subpoenaed bank and telephone records, and electronic monitoring.

The agents learned Schilling had met Gabriel in 1993 during a Thanksgiving vacation in Miami. Schilling had some "Special K," the street name for Ketaset, which they both used to get high.

Schilling told agents that after he and Gabriel returned home from Miami, he asked Gabriel to supply him with more Special K, and that Gabriel had done so twice. On March 28, at OCI's request, Schilling ordered more Special K from Gabriel, receiving 30 vials, worth about $1,350, on April 28.

Testing by FDA's Forensic Chemistry Center, in Cincinnati, determined the substance in the vials was indeed ketamine.

In October, OCI agents asked the New York U.S. attorney to file a complaint. Gabriel was arrested Nov. 16, 1994, on charges of tampering with Ketaset by altering it so that it could be used illegally, thus risking injury to another person.

On June 8, 1995, Schilling pleaded guilty to an information charging him with misbranding a prescription veterinary drug in interstate commerce.

Gabriel's deferred prosecution program requires him to report to a pretrial services officer, obey laws, associate only with law-abiding individuals, and remain within the Southern and Eastern Districts of New York or the District of New Jersey unless his supervising officer grants him permission to leave. If Gabriel meets these conditions throughout the six months, the government will not prosecute him.

Dixie Farley is a staff writer for FDA Consumer.

Cheese Maker Says He Wants Out

An Ohio cheese manufacturer and distributor told the government he would go out of business rather than comply with a court order to rid his operations of dangerous bacteria and filth.

On July 12, 1995, Dominic Gangale, owner of Union Cheese Co., Sugarcreek, Ohio, told U.S. Magistrate Judge Patricia A. Hemann in the U.S. District Court for the Northern District of Ohio that the firm had ceased all cheese production, and he wanted only to sell the cheese in stock.

The judge had ordered the firm on June 16 to stop making and distributing cheese until it could ensure that the cheese was not contaminated with pathogenic bacteria or filth.

In 1994, samples of cheese had tested positive for Listeria monocytogenes, an organism that can cause serious and sometimes fatal infections in small children, frail and elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms, such as high fever, severe headaches, stiffness, nausea, abdominal pain, and diarrhea, Listeria infection can cause miscarriages and stillbirths in pregnant women.

Union Cheese produced about 20,000 pounds (9,072 kg) of Swiss cheese daily and usually kept an inventory of about 1 million pounds (454,000 kilograms) of cheese, both its own Swiss, as well as different kinds from other manufacturers.

On Sept. 29 and 30, 1994, Phillip Pontikos, an investigator with FDA's Brunswick, Ohio, office, inspected Union Cheese as part of the agency's scheduled surveillance of food manufacturers.

Pontikos found numerous violations of good manufacturing practices. In one container of brine and cheese, he counted more than 30 floating dead flies. He also saw dead insects on blocks of cheese and hundreds of dead insects, cobwebs and dirt on windowsills.

He also noted that there was no hot running water in the restrooms, brine room, or laboratory.

Pontikos discussed these problems with Annette Gangale, daughter of the owner. She agreed to discuss the problems with her father.

Pontikos sent samples of cheese to FDA's lab in Cincinnati. One sample tested positive for Listeria.

The agency advised the firm of the sample analysis, and as a result, Union Cheese recalled cheese from the contaminated lot. But the recall could not be completed because the company had not properly coded cheese lots. Gangale admitted that he did not know exactly what firms had bought the cheese.

On Oct. 27 and 28 and Nov. 7, Pontikos returned to Union Cheese and collected more samples of cheese and environmental samples, including brine and various materials from the floor. Several of the environmental samples tested positive for Listeria.

On Nov. 29, Pontikos, along with FDA investigators Steve Kilker and Frederick Lochner, returned to Union Cheese. In a two-week-long investigation, they found many of the same problems Pontikos had seen previously, as well as:

raw and finishing operations not being kept sufficiently separate
Swiss cheese being shipped before the end of the required 60-day aging period
ceiling condensation dripping onto uncovered cheese
peeling ceiling paint directly above the cutting table
cutting tools that could not be sanitized because of wooden handles and rusty screws.

On Feb. 22, 1995, the agency asked the Justice Department to initiate injunction proceedings against Union Cheese. But, to confirm that the problems still existed, the court ordered another inspection. When FDA investigators returned to inspect the firm from May 16 to 18, many of the same insanitary conditions still existed. One instance in which some effort was made to improve things only made matters worse. A fan, placed in the cutting room to prevent condensation from dripping on cheese, drew air into the facility from the direction of the firm's sewage treatment plant.

At a three-day hearing begun June 5, Gangale did not dispute the investigators' findings. He said, however, that, in his opinion, these problems did not violate good manufacturing practices.

At the end of the hearing, Judge Hemann ordered Union Cheese to close until violations were corrected.

On July 12, the court entered a supplemental order clarifying the conditions the defendants must comply with before they would be allowed to sell cheese in stock. Those conditions called for FDA to supervise the testing of each lot of cheese for Listeria and to ensure that the cheese would be handled under sanitary conditions.

All the in-stock cheese--3,981 blocks, each weighing 200 pounds (90.7 kg)--tested free of Listeria, but one lot was insect-infested. All were sold except for the insect-infested lot (72 blocks). At press time in February, Gangale still had not destroyed the insect-infected lot.

--Dori Stehlin

Animal Drug Maker Overhauls System

A major manufacturer of generic animal drugs chose to overhaul its injectable drug processing system following a government seizure of thousands of dollars worth of drugs, a partial factory shutdown, and a consent decree in which the company agreed to correct violations.

At press time in February, Anthony Products Co., of Arcadia, Calif., was planning to have its new injectables' operation at its El Monte, Calif., plant up and running this spring, pending FDA's concurrence, according to Mary LoVetere, a compliance officer with FDA's Los Angeles district office. The company already replaced its injectables' system at its Irwindale, Calif., plant.

The company reportedly bought new equipment, hired new people, and revised manufacturing procedures and controls so that its injectable drug product line would comply with good manufacturing practices (GMPs), she said.

Anthony Products makes various veterinary medicines, including injectable forms of antibiotics, anesthetics and other drugs for large and small animals. It manufactures drugs under its own brand name and other companies' labels.

The company agreed to correct GMP violations in a consent decree it signed Aug. 3, 1995, in the U.S. District Court for the Central District of California.

In March 1995, U.S. marshals had seized, at FDA's request, about 200 drums of drug ingredients and 8,000 vials of injectable drugs. The company's injectable drug system at its El Monte plant has been idle since. Its penicillin production line at its Irwindale plant resumed manufacturing in June 1995.

Previously, FDA sent Anthony Products several warning letters for failing to follow GMPs for its injectable drugs. The most recent warning was issued in May 1994, and company officials responded that they would correct the violations.

However, during a reinspection in August and September 1994, FDA investigators found continuing problems, as well as some new ones. The problems revolved around the company's failure to ensure the sterility and quality of its injectable products.

FDA decided to seek a seizure to spur the company to correct repeated violations and to make sure that adulterated drugs did not reach consumers.

On March 3, 1995, U.S. marshals seized all injectable drugs and injectable drug ingredients in Anthony's possession.

In the consent decree, FDA agreed to return the raw ingredients to Anthony Products for testing under GMPs. The seized drugs will be disposed of by U.S. marshals.

--Paula Kurtzweil

Filth in Fish Fillets Closes Business

A food business closed after an FDA inspection found flies, condensate dripping on smoked salmon fillets, racks of product placed against fish-residue-encrusted walls, and fillets being trimmed with rusty pliers.

FDA investigators found those and other unsanitary conditions at Sotra Smoked Fish, U.S.A. Inc., Kingston, N.Y., after routine agency sampling showed products contaminated with Listeria monocytogenes, bacteria that can cause potentially fatal illness.

About 25 percent of such infections result in death, said FDA microbiology expert Joseph Madden, Ph.D., in testimony concerning Sotra. "Symptoms are most severe in the elderly, infants, pregnant women, and those people whose immune systems are impaired," he said.

Sotra principal officers Olav Isaksen and Joel Kudlowitz signed a consent decree of permanent injunction last June 23 in the U.S. District Court for the Northern District of New York. Isaksen is president and treasurer, and Kudlowitz is vice president and secretary. Sotra is closed until it can meet the decree's terms, which include a cleanup and an extensive testing program supervised by FDA's Buffalo district office.

On June 1, 1994, investigator Thomas Morgan, of FDA's Boston district office, sampled Sotra's fillets at a smokehouse in Bennington, Vt., as part of the agency's seafood sampling program. Testing at FDA's Winchester Engineering and Analytical Center, in Winchester, Mass., detected Listeria, and Boston informed the agency's Buffalo office.

Buffalo FDA investigator Margaret Slimbach visited Sotra July 7 to present the test results.

Meanwhile, according to Buffalo compliance officer Raymond Kent, FDA discussed Sotra with the New York State Department of Agriculture and Markets, which inspects manufacturers for FDA under contract. In August 1993, the agency learned, the state had sent Sotra a warning letter and levied a $300 fine because of continuing unsanitary conditions seen during several state inspections in 1992 and 1993.

On July 12, Slimbach and Samuel Eskenazi, a microbiologist with FDA's Northeast Regional Laboratory, began an extensive inspection of the food plant. On the third day, Sotra agreed to recall the lot sampled in Vermont.

The FDA team discovered gross unsanitary conditions and practices. The freezer and cooler handles, for example, were slick with dirty residues. And the cooler door had been left standing open about an hour and a half, the inside temperature unmonitored. Using an FDA thermometer, Slimbach found the temperature to be 60 degrees Fahrenheit (15 Celsius), when it should have been below 40 F (4 C). (Listeria bacteria can grow at 40 F, but not as fast as at higher temperatures.)