A medical device company with a facility in the Sylmar area of Los Angeles has been warned by the Food and Drug Administration of potential issues that could compromise the safety of patients. The company must react accordingly or risk further action by the FDA.
The St. Paul, Minnesota-based St. Jude Medical was the recipient of the warning letter, which asked the company to address certain quality control and manufacturing shortfalls that could lead to the endangerment of patients. The warning comes following a recent inspection by the safety organization which uncovered documentation and production errors when it came to defibrillators.
This is not the first time that St. Jude has been scrutinized by the FDA. Wires that attach the defibrillator to a patient reportedly featured quality deficiencies in recent years, prompting a recall of Riata wires in 2011. This was followed by two additional recalls in 2012, and at the behest of the FDA, St. Jude was tasked with putting together a study that sought to determine what wire insulation failures could do to patients receiving treatment.
As part of the latest warning letter, no recall will be issued, and the facility has been allowed to continue producing and distributing items. However, until the facility has assuaged the FDA’s worries, no new products will receive FDA approval.
Let’s hope that the facility can get their problems corrected so that patients can have their safety assured in the future.