Washington state firm prosecuted for distributing non-sterile drugs - For Your Health Inc

FDA Consumer, May, 1994 by John Henkel

A Kent, Washington, pharmacy received a $6,000 fine and three years' probation after its president pleaded guilty to manufacturing and distributing a non-sterile injectable drug, Magnesium-ATP.

Raymond Suen, 45, who headed For Your Health Inc., also received a $5,000 fine and three years' probation when sentenced last Feb. 4. A separate civil suit brought against Suen by the Drug Enforcement Agency for illegally manufacturing the drug testosterone resulted in an additional $5,000 fine. Earlier, following a search that yielded incriminating evidence, Washington state revoked the pharmacy license held by Suen's company. He may no longer sell prescription drugs in his store but may continue the business as a health-food establishment.

Suen ran afoul of the law when he started manufacturing his own drugs to sell. An FDA inspection uncovered serious mold and bacterial contamination in samples of the firm's injectable Magnesium-ATP, a drug promoted for treating cardiac conditions.

Injecting non-sterile drugs can cause fever, shock, blood infection, and even death. According to Tom Pickarski, compliance officer for FDA's Seattle district, there were no confirmed adverse reactions due to consumer use of the drug.

Suen's wrongdoing might have gone undiscovered had it not been for an incident Piekarski calls "serendipity." A 1991 consumer complaint tipped off FDA's Seattle office that For Your Health was selling L-tryptophan, a substance FDA banned from U.S. sale in November 1989. FDA inspected the pharmacy in July 1991 and found L-tryptophan in the store. Suen then volunteered to recall distributed L-tryptophan.

Investigators from FDA and the Board of Pharmacy returned in August 1991 to ensure that Suen had undertaken the recall. While inspecting the pharmacy, investigators saw intact vials of injectable drugs that a customer had returned. Noticing mold in the vials, they questioned Suen, who told them the product had been made at his analytical laboratory, Meridian Valley Clinical Laboratory.

(FDA later determined that chemists from Meridian Valley manufactured more than 1,100 vials of Magnesium-ATP between January and December 1991. In 1992, Suen established manufacturing capabilities at the pharmacy and produced an additional 300 vials.)

In September 1991, FDA investigators attempted to inspect Meridian Valley but initially were refused entry. The firm's attorney then agreed to allow a 20-minute walk-through, during which investigators saw paraphernalia--stoppers, crimps, and empty glass vials--used for injectable products. Soon after, an informant told FDA that Suen was gearing up for illegal large-scale drug production. Later, investigators also found, in a laboratory trash bin, boxes of intact returned vials containing mold-contaminated Magnesium-ATP.

In May 1992, FDA served a warrant and searched the facility. FDA investigators seized approximately 50 vials of Magnesium-ATP, alone, with documents, promotional material, and catalogs.

Suen conducted a voluntary recall of Magnesium-ATP immediately after the search, but was able to recover only 106 vials from among hundreds distributed.

FDA evidence indicated that Suen's chemists tried to use sterile techniques in manufacturing the drug. But with no training in proper procedures, their efforts failed. Also, the environment at Suen's laboratory was inadequate to produce a sterile product. For example, chemists made Magnesium-ATP in the same area where they performed tests on urine, blood and feces.

FDA investigators determined that Suen and his chemists were unaware of the good manufacturing practice procedures required by food and drug law to ensure product sterility. The U.S. Pharmacopoeia prescribes a 14-day sterility test period to ferret out bacteria- or mold-contaminated batch portions. Instead, Suen's firm observed a three-day test period described in a general laboratory chemistry book. As a result of Suen's method, as many as a third of all prepared batches emerged contaminated, yet the firm falsely labeled some of them sterile. FDA later concluded that none of the 1,400 vials Suen's company made between January 1991 and May 1992 were reliably sterile.

In the related Drug Enforcement Agency civil proceeding, Suen pleaded guilty to sending a controlled substance, testosterone, to an Oregon laboratory to be encapsulated for sale.

N.J. Firm Ordered to Stop Selling Contaminated Drugs

What began as a routine inspection of an East Rutherford, N.J., drug manufacturer ended in a product recall, a mass seizure, and a court order to stop the firm from making and selling drugs under unsanitary and other violative conditions.

Ambix Laboratories, Division of Organics Corporation of America, signed a consent decree of permanent injunction Jan. 4, 1994. The decree resulted when an FDA investigation found that two of the firm's products were contaminated with bacteria and the firm's manufacturing and laboratory operations were not in compliance with government regulations.

FDA has received no reports of illness or injury resulting from use of the drugs. In signing the consent decree, Ambix agreed to stop selling drug products not manufactured under good manufacturing practice (GMP) requirements.