A recent report by the United States Food and Drug Administration showed a significant number of problems with St. Jude Medical’s Datura pacemaker leads. The report spooked investors and led to an 11 percent decrease in stock prices for the company.

According to the FDA report, 11 problems were found at the company’s plant located in Sylmar, California. This latest issue follows a recall of the company’s Riata leads in 2011. In October of this year, CEO Daniel Starks publicly stated that the company may receive a warning over processes at its Sylmar plant.

The FDA’s Form 483 detailed the 11 problems at the plant. The FDA also released an eight page report that detailed the issues. According to the FDA, the company’s design verification activities were not adequate. In addition, there were multiple issues with the validation protocol for the company’s Datura leads.

In the report, an FDA inspector noted, "Your firm was unable to clearly identify the full content of your Durata design history file, for example: I was unable to determine when your firm approved your Durata design inputs, outputs, verification, validation, design transfer and when you conducted your final approval of your Durata design. I was also unable to determine which inputs were changed or unchanged from 1997 onward, which is the origination of your Durata design."

References

http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofGlobalRegul...