FDA raises manufacturing concerns at CryoLife

FDA raises manufacturing concerns at CryoLife

February 18th, 2013 // 6:10 pm @ jmpickett

The Food and Drug Administration has raised concerns about manufacturing and management processes at CryoLife Inc.

The Kennesaw, Ga.-based company (NYSE: CRY) is an implantable biological medical device and cardiovascular tissue processing company.

In the early aughts, CryoLife paid millions of dollars to settle suits involving allegedly contaminated tissue products. In July 2005, CryoLife reached a $23.3 million settlement for a class-action lawsuit that alleged it had inadequate disclosures prior to the FDA’s August 2002 tissue recall.

Late last year CryoLife received a Form 483 filing from the FDA, detailing nearly 20 issues involving the handling of tissue and device manufacturing at its plants.

The report was the result of a routine scheduled inspection of CryoLife’s plants, conducted over a four week period last September and October, company executives told analysts in a conference call Feb. 14 .

“We initiated significant efforts to address the FDA’s observations and provided three written responses to the FDA detailing our corrective action plans,” said David Fronk, CryoLife’s vice president of regulatory affairs and quality assurance.

On Jan. 30, CryoLife received a warning letter from the FDA involving, in part, issues that were not corrected or resolved from the Form 483.

Specific concerns addressed by the FDA and warning letter include ensuring that complaint investigations are adequately conducted, assuring that management reviews the company’s quality system on a regular and sufficient basis, preventing the reoccurrence of deficiencies in personnel training, and providing additional information describing changes in the company’s disinfectant system.

“We continue to take this matter seriously and intend to fully respond to the FDA’s concerns,” Fronk said. “We intend to provide our response to FDA before the end of next week.”

On the conference call one analyst questioned whether the FDA’s warning letter might have an impact on CryoLife’s revenues if customers pulled back.

CryoLife CEO Steve Anderson responded: “I specifically asked sales management … regarding the feedback from the field, was there any adverse or were there any adverse comments regarding the letter, and the answer of that was we have not had a single account raised that question.”