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FDA Warns Pfizer, Abbott

February 12, 2002

NEW YORK (AP) _ The Food and Drug Administration has issued warning letters to Pfizer Inc. and Abbott Laboratories Inc. telling each company to correct manufacturing practices at one of their plants.

The letter to Pfizer, posted on the FDA’s Web site Tuesday but dated Jan. 30, said the FDA found quality control problems at a plant in Terre Haute, Ind. that manufactures injectable antibiotics. The letter said conditions at the facility were not adequate to ensure that the drugs are the proper strength and quality and that they are free from contamination. The company has 15 days to respond to the letter.

Pfizer said it was upgrading its facility to comply with FDA demands. The New York-based pharmaceutical company said the letter referred to 31 specific issues and that the company had corrected 21 of them.

A Jan. 30 letter sent to Abbott, also posted Tuesday, said an FDA inspection of a facility in Salt Lake City determined that the facility, which manufactures catheters, surgical kits and infusion accessories, had quality control problems. The letter said that the company had not implemented all the changes it had said it was going to make in May 2000 to eliminate or minimize failures in its catheter balloons. In May 2000 Abbott voluntarily recalled a batch of the catheters even though the devices were no threat to a patient’s health, said Abbott spokeswoman Tareta Lewis.

Lewis said Abbott is preparing its response to the FDA.

The companies must respond to the FDA within 15 days of receiving the letters with a plan to correct the problems. The timetable for fixing the problems is typically laid out in the response. The amount of time allotted for fixing the problems varies depending on the severity of the situation.

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