Covidien gets FDA warning letter

Sep 24, 2008

Radiopharmaceutical firm Covidien has received a warning letter from the U.S. Food and Drug Administration (FDA) for manufacturing issues at a plant that produces the company's Ultra-TechneKow-DTE technetium-99m-based product.

The August 12 letter states that the FDA found "serious deviations" from current good manufacturing practice (cGMP) regulations during an inspection in March 2008 at the facility in Maryland Heights, MO. The deviations cause Ultra-TechneKow to be "adulterated" within the meaning of the U.S. Food, Drug, and Cosmetic Act, the letter states.

Most of the deviations regarding Ultra-TechneKow manufacturing concern levels of molybdenum-99 breakthrough, which occurs when molybdenum-99 is eluted along with technetium-99m from a technetium generator. The FDA has asked Covidien to explain why it has chosen certain methodologies for setting breakthrough limits, as well as what the company has done to investigate incidents of molybdenum breakthrough that occurred in 2007.

The letter advises Covidien to "take prompt action" to correct the violations cited in the letter and also informs the company of the various regulatory steps the FDA could take if the firm fails to comply.

A Covidien spokesperson said the company is moving to address the issues raised by the letter.

"Covidien is obviously treating this FDA warning letter very seriously, and we are committed to working closely with the FDA to resolve their concerns," said JoAnna Schooler, director of communications. "We have cooperated fully with the agency during and after the inspection of our Maryland Heights manufacturing facility, responded to the warning letter in a timely manner, and Covidien will continue to comply with the actions that the FDA has requested."

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