OCT. 31–CHICAGO, IL–Abbott Laboratories continues to have trouble complying with federal regulatory drug manufacturing standards.

In a warning letter, dated Oct. 15, the U.S. Food and Drug Administration (FDA) says deviations from current good manufacturing practices (cGMPs), including failure to prevent contamination and not validating sterilization, HVAC and process equipment, significantly breeched quality control at Abbott’s Austin, TX, plant.

Tareta Adams, a spokesperson for Abbott, told CleanRooms that upgrades and enhancements to the Hospital Products Division’s plant and procedures are already under way to correct violations outlined by the FDA.

“We are taking all of the comments and everything noted in the letter very seriously, and we’ve already made some progress,” Adams says. “We had some updates to our policies and procedures and conducted additional training to ensure the implementation of those procedures.”

Abbott received a warning letter in January listing similar violations at a Utah plant, and another in July cited poor record-keeping practices at the company’s Chicago plant. More than a year ago, Abbott received a $100 million fine for serious deficiencies in the production of medical diagnostics and screening devices and for ignoring FDA warning letters for six years.

Adams says Abbott is working with “third party experts” in revalidating facility, which manufactures intravenous pharmaceutical and irrigation products. Abbott has also launched a company-wide campaign to assess its entire global operation in an effort to improve quality control.

“We are addressing specifics in the letter and, in all honesty, we are looking at things from a global view,” Adams adds.