FDA warning over Cardiac Science AED plant:
This article was originally published in Clinica
The US FDA has issued a warning letter to Cardiac Science following a January inspection of its Minneapolis production site for automated public access defibrillators. The company said it had responded to the letter by beginning to amend its quality system and writing to the FDA to explain the steps it has taken. It added that the warning letter "did not relate to the usability, safety or efficacy of the company's AEDs".