• Alleged Sterility Deficiencies Behind Warning Letter to Medical Device Company

    A warning letter to Atrium Medical Corporation , a new Hampshire-based medical device manufacturer, claims at least four of the company's products are adulterated as a consequence of poor manufacturing practices. The 11 October letter from the US Food and Drug Administration (FDA) cites a number of findings made during the course of an inspection made between 31 July and 7 September. Among the most troubling allegations made by FDA is the systematic failure of steril...