13 April 2004 18:47 [Source: ICIS news]
WASHINGTON (CNI)--The US Food and Drug Administration (FDA) said Tuesday it has settled a case against an Illinois drug repackaging firm that allegedly imported unapproved drugs last year.
The company, Phil and Kathy’s Inc, signed a settlement in the US District Court for the Northern District of Illinois agreeing to comply with FDA regulations meant to ensure pharmaceuticals are effective, packaged safely and produced under current good manufacturing practice (GMP) rules.
The company has done business under the names Local Repack, Alliance Wholesale Distributor and Local Pharmacy.
Products linked to Phil and Kathy’s were among thousands of unapproved drug imports seized during a sweep last year, the FDA said, some of which were labelled in foreign languages or labelled as repackaged. The FDA said the company imported unapproved products labelled in Spanish and Portuguese.
The case follows FDA and US Customs investigations in Illinois and other US states concerning illegal re-imports of US-manufactured drugs from Canada and other foreign countries. The investigative sweeps late last year and earlier this year also were aimed at uncovering counterfeit drug operations.
Under a consent decree with the FDA, Phil and Kathy’s cannot produce or distribute drugs until the FDA determines the firm’s repackaging process complies with GMP standards. The agency can fine Phil and Kathy’s if the company distributes or imports drugs that do not comply with government regulations, the FDA said.
Lester Crawford, acting FDA commissioner, reiterated today that FDA regulatory enforcement is meant to enforce laws designed to ensure safety and quality.
"Products that are illegally distributed outside this protective system pose a serious threat to patients," he said in a statement.
Charges against Phil and Kathy’s importer, Genendo Pharmaceuticals, are still pending in court.
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