FDA threatens fines, regulatory action over Synthes' GMP problems

The international medical device company Synthes has been producing rods, power tools and screws for orthopedics for years. But now the FDA is putting the screws to Synthes.

Finding complaint handling and production standards sorely inadequate at Synthes' West Chester, PA, plant, the FDA has issued a no-nonsense warning letter to the medical devicemaker, threatening it with "regulatory action" if it does not promptly fix the problems. 

The FDA gave Synthes 6 months to address the issues, produce an audit by an outside expert that they are being resolved, and provide certification from the CEO that the action plan has been reviewed and is being implemented. Failure to do so could result in regulatory actions including "seizure, injunction, and/or civil money penalties."

Additionally, the FDA said premarket approvals for some of the company's medical devices could be withheld, and "Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected."

The severity of the threats is perhaps not surprising given that Synthes is the company whose former president and several other executives were convicted of conducting medical trials on bone cement without FDA approval. The company agreed to pay more than $23 million as part of a conviction agreement. It still faces civil litigation from patients treated in those trials. 

Synthes says it is getting right on the FDA's concerns. In email to Reuters, company spokesperson Gilgian Eisner said: "We will co-operate and work diligently with the FDA until these deficiencies are fully resolved."

But the timing of the deadline is interesting. The company has until Aug. 10 to produce certification from the CEO that the problems are fixed but by then Synthes will probably be owned by Johnson & Johnson ($JNJ). J&J last year agreed to pay $23.1 billion to buy the company and intends to meld it with its DePuy Companies, which has had its own FDA and litigation issues because of failures of its hip implant products.

The J&J and Synthes deal is expected to close in the first half of this year. So it raises the question of whether it will be the CEO of J&J who will have to review and certify the report. And of course, J&J will have a new CEO by then. Alex Gorsky was recently named to succeed William Weldon, who is retiring as CEO. That transition is slated to occur at the shareholder meeting April 26.

A Johnson & Johnson spokesperson declined a request from FiercePharmaManufacturing to comment since the acquisition is not complete, but if Gorsky does have to concern himself with the details of GMP failings at Synthes, at least he has experience. He takes over as CEO after running J&J's own medical device business.

- read the FDA warning letter
- get the Reuters story
- here's the J&J/Synthes acquisition release

Special Report: Johnson & Johnson/Synthes - Top 10 medical device deals of 2011