Genentech Cited for Lapses in Quality Control

Genentech Inc., the world’s oldest biotechnology company, was cited by the Food and Drug Administration for quality-control lapses, most related to production of its Pulmozyme drug for cystic fibrosis.

The FDA sent the warning letter, dated Dec. 14 and released Tuesday, to Susan Hellman, Genentech’s chief medical officer, based on an inspection of company facilities at its headquarters in South San Francisco from Aug. 7 to Aug. 24.

Genentech used expired material to manufacture Pulmozyme in January, the FDA said in the letter. The company also failed to obtain approval before distributing two bulk lots of Pulmozyme that had been contaminated and then refiltered, the letter said.

“We’ve moved very quickly to address these issues,” said Genentech spokesman Marie Kennedy. “These [observations] haven’t caused any safety issues. All products shipped met all safety and quality standards.”

Kennedy said it was the first time that Genentech has received a warning letter from the FDA.

Shares of Genentech rose $1.56 to close at $80.94 on the New York Stock Exchange. The shares have gained 20% this year.

In October, Genentech said it recalled one lot of Pulmozyme because the company had added an unapproved filtration step in the drug’s production. A company official said at the time that more than 200,000 doses of the drug were recalled voluntarily.

The FDA also cited the company for its failure to obtain quality-control approval for reprocessing of its Activase clot- busting drug after a leak was detected in the manufacturing process.

The FDA sends hundreds of warning letters to companies each year, and only a small number result in significant agency action. Still, the letters can be the last notice before the FDA takes steps such as holding up approvals of new products or pursuing civil fines.