Synthes, Inc., the medical device maker with U.S. headquarters in Chester County, received a multi-point warning letter from the U.S. Food and Drug Administration that criticizes the company for not following good manufacturing procedures and for not responding properly to complaints about products.
The FDA warning letter was posted on the agency site Tuesday and can be found here.
Previous Synthes coverage in the Inquirer can be found here.
Though Synthes could be fined, it was unclear at midday Tuesday what, if any, impact the warning letter would have on the company which is supposed to be operating under a Corporate Integrity Agreement, with outside monitors.
The FDA warning letter was addressed to Chief Executive Officer Michel Orsinger.
Orsinger was the Synthes official who signed the Corporate Integrity Agreement, which was part of the 2010 settlement of charges brought by the U.S. Attorney's Office in Philadelphia after the company promoted bone cement for use in spinal surgery despite not having approval from the FDA for that procedure. The company also trained surgeons and delivered the product to them so they could conduct an unapproved clinical trial on patients. Three patients died on the operating table.
A call to Synthes U.S. headquarters in West Chester was referred to the world headquarters in Switzerland. The spokesman there, Gilgian Eisner, could not be reached for comment.
Reuters reported that Eisner said in an email, "We will co-operate and work diligently with the FDA until these deficiencies are fully resolved."
Four Synthes executives - Michael Huggins, Thomas Higgins, Richard Bohner and John Walsh - are federal prison now after pleading guilty to charges related to their role in the scheme.
Then-CEO, current board chairman and largest stockholder Hansjorg Wyss was not charged.
Johnson & Johnson announced in April 2011 that it would pay $21.3 billion in Swiss francs and J&J stock to buy Synthes.
Orsinger will get bonuses as an outgoing Synthes leader and a new job with J&J.
Last week, the families of two of three patients who died filed suit against Synthes.