Compliance woes haunt Abbott

12/01/2002

By Mark A. DeSorbo

CHICAGO, IL—ABBOTT.LABORATORIES continues to have trouble complying with federal regulatory drug manufacturing standards as a recent inspection of its Austin, TX plant turned up mold and rust in critical manufacturing areas and the intravenous (IV) solutions it produces.

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 Hospital Products Division.

Tareta Adams, a spokesperson for Abbott, told CleanRooms that upgrades and enhancements to the Hospital Products Division's plant and procedures are already underway 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."

In the six-page letter from Michael A. Chappel, a district director for the FDA, several instances were outlined that caused drug products manufactured by Abbott "to be adulterated."

Numerous breaches of contamination control and validation were noted, but several sections of the letter that may have provided more specifics on the violations were blackened out from the letter, which is posted at http://www.fda.gov/foi/warning_letters/g3626d.pdf.

Contamination control violations include failures to:

• Validate computer-monitoring systems for sterilizers, HVAC and water purification;
• Prevent contamination from occurring in critical areas and failure to establish;
• Follow written standard operating procedures for the cleaning and maintenance of equipment;
• Establish scientifically sound product sampling plan and to thoroughly review batch failures;
• Maintain records for regular evaluation of quality standards.

Chappell pointed out that process controls and monitoring systems were not validated to current standards, which affected the operations' continuous sterilizer solution preparation equipment and process, HVAC components, and reverse osmosis water purification system.

Abbott also failed to follow general good employee practices, which fall under cGMPs, to prevent contamination from occurring during manufacturing and processing operations.

"General good employee practices states: do not bring in or use rusty racks, tools, furniture, etc. in the clean areas. However, rust was observed on the metal support backing of at least four stools in critical filling zones," Chappell admitted.

During the late-August inspection, compliance officers observed rust covering the overall surface of a stainless steel rack used to transport equipment parts into and out of the critical-filling zones. Rust and corrosion were also observed on the base and impeller blades on an active air sampler, which was in use in the critical manufacturing areas.

"There are numerous HEPA filter metal grills that have a buildup of rust-like material and discoloration," Chappell points out. "Two HEPA filter grills are bent and reveal a buildup of mold-like and other unknown material, and these grills are located immediately above the filling zone."

Standard operating procedures for cleaning and maintaining manufacturing equipment as well as product sampling were the reasons for numerous instances of product complaints, the warning letter indicates.

Previous investigation revealed metallic particles and synthetic fibers in the ports of IV filling operations as well as the presence of a "brown floater in solution," that the FDA said could have been corrugated paper.

"This appears to be a persistent problem," Chappell writes. "In a previous inspection, after a complaint was received regarding mold in the product, the presence of mold was confirmed by analysis. The investigation did not indicate any review or evaluation of any environmental monitoring data as a result of the confirmation that there was mold growth on the caps or any attempt to ascertain the source of the mold.

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.

Abbott's Adams says the company is working with "third-party experts" in revalidating the Austin facility. Abbott, she adds, 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 improving things from a global view," Adams adds.