Wyeth-Ayerst to Pay $30-Million Fine

Associated Press

Vaccine maker Wyeth-Ayerst Laboraties agreed to pay a $30-million fine for repeatedly violating federal drug-quality rules at two of its East Coast manufacturing plants, including a flu-shot factory whose temporary closure contributed to this year's delay in flu vaccine. A subsidiary of American Home Products, Wyeth-Ayerst signed the consent decree with the Food and Drug Administration, which also requires it to take specific steps to improve quality at the plants on a preset schedule or face up to $5 million more in fines. The FDA said it never found contaminated Wyeth products and is aware of no illnesses. It nevertheless called the manufacturing problems serious violations of rules meant to ensure that drugs and vaccines are sterile and of high quality. The consent decree was prompted because Wyeth did not correct violations despite repeated FDA inspections, warnings and even the seizure last June of hundreds of doses of prescription drugs and vaccines made at one of the plants. The violations dated to 1995. Among products made at the problem plants is flu vaccine. AHP shares fell 63 cents to close at $56.06 on the New York Stock Exchange.

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