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General Therapeutics Raid Nets $300,000 Worth of Defective Drugs Manufactured in Filthy Conditions

Nov 2, 2007 | Parker Waichman LLP General Therapeutics, a St. Louis, Missouri drug manufacturer, was raided by federal agents yesterday amid suspicions that it maintained a secret drug manufacturing area and was producing unsanitary medications.   General Therapeutics had received a Food & Drug Administration (FDA) Warning Letter regarding unsanitary conditions at is facility in 1999, and in 2000 indicated to the agency that it no longer manufactured non-prescription medications.  But it was apparent from evidence removed during yesterday’s General Therapeutics raid that this was not the case.

General Therapeutics lists its business as the manufacturing, marketing and sale of nonprescription pills, creams and lotions.  The General Therapeutics raid followed an inspection of the facility earlier this year by the FDA.  According to prosecutors, that inspection discovered live and dead beetles in containers of vitamins, dead cockroaches near equipment and rodent droppings near a mixer.  During that same inspection, the FDA found equipment that had not been cleaned, paperwork and testing problems, and water damage to equipment.  Inspectors had also found chemicals at the General Therapeutics facility that had deteriorated to the point that they were explosive, prompting the inspectors to order an immediate evacuation of the building.  The FDA also found evidence during the General Therapeutics inspection that the company was making over-the-counter medications, contrary to earlier claims.  According to court documents, the FDA inspectors found that workers at General Therapeutics had constructed several rooms behind false walls in order to conceal the production of its defective drugs.

In a complaint filed in the US District Court, prosecutors alleged that General Therapeutics manufactured “numerous” dietary supplements and over-the-counter medications for humans and animals using the same facilities and equipment observed by FDA inspectors.  It asked the court for permission to seize the drugs because they could have been prepared in conditions where it was likely they would be contaminated by filth. In the complaint, prosecutors mentioned three medications made by General Therapeutics that were of particular concern.  Those were Vitrin, a vitamin supplement; NC Solution, an anti-fungal; and Pyran-50, a pet de-worming product.

Yesterday’s raid was not the first time that General Therapeutics got in trouble for unsanitary manufacturing practices. In 1999, the FDA found similar problems at the General Therapeutics facility and issued the company a warning letter.   The company never responded to that letter, so FDA inspectors returned to General Therapeutics in 2000, when the company’s owner told them that it had stopped manufacturing over-the-counter medications.   During that time, the FDA inspectors found no evidence that General Therapeutics was involved with such manufacturing.

Federal agents reportedly seized more than $300,000 worth of over-the-counter medications from yesterday’s General Therapeutics raid.   The government is seeking to have those medications destroyed.

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