Fda Pans Bayer’s Spokane Plant Some Production Has Been Interrupted

The U.S. Food and Drug Administration Tuesday released a letter criticizing quality assurance at the Bayer AG plant in Spokane.

The facility manufactures more than 100 products for treating allergies. Although no products have been recalled as a result of the FDA’s findings, Bayer spokesman Don Hyman said some production has been interrupted and customers are being directed to alternative suppliers until problems at the plant, which employs 260 people, are overcome.

“There have been shortages,” Hyman said.

The letter to Bayer from James Simmons, compliance director for the FDA’s Center for Biologics Evaluation and Research, was signed Jan. 30 of this year.

Hyman said the findings apparently were made public as a result of a routine purge of dated FDA correspondence.

Officially called a warning letter, the issues stemmed from an August 1996 inspection of the facility at 3525 N. Regal.

Inspectors listed 45 separate deficiencies covering maintenance, cleanliness, process-control, record-keeping and training.

For example, the letter noted “Live insect, dust and debris were observed near the raw material sampling area.” Other observations were as minor as chipped paint.

Hyman said the attention to detail is typical of FDA inspections. “They are nothing if not careful and meticulous,” he said.

But Hyman added that Bayer is not minimizing the findings, and is near completion of a major engineering study of the Spokane plant.

“We have cooperated fully,” he said. “We’re committed to doing whatever it takes to maintain our top-quality facility in Spokane.”

Hyman said the FDA, a part of the U.S. Department of Health and Human Services, reinspected the plant last April.

Last month, David Stellingworth was named vice president for Allergy Products of Bayer’s Pharmaceutical Division North America. The Spokane plant is the center for those operations.

Simmons said the FDA issues hundreds of letters each year like the one sent to Bayer.

Although common, he said, they indicate a level of concern a step beyond merely notifying a company of inspector observations.

Companies that receive letters “have undergone several layers of scrutiny,” Simmons said.

Each case is unique, he said. In the case of Bayer, “We are relatively satisfied with the actions that have been taken and the progress that has been made.”

Bayer, based in Laverkusen, Germany, is one of the world’s largest drug and chemical companies, with sales of $32.4 billion.

, DataTimes