Alleged Sterility Deficiencies Behind Warning Letter to Medical Device Company

| 01 November 2012 | By Alexander Gaffney, RAC •

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 sterility controls across Atrium's manufacturing program. For instance, the company failed to, "Validate with a high degree of assurance a process whose results cannot be fully verified by subsequent inspection." Specifically, Atrium did not "adequately validate" the process used to sterilize all 39 of its devices, said FDA. The warning letter noted the company was in the process of directly addressing this deficiency, but requested an explanation of subsequent testing data be made available to regulators.

Further in the letter, FDA said it found four complaints related to the company's C-QUR hernia mesh device. The letters contained reports of infections associated with the C-QUR products, but FDA said the complaints were closed without obtaining the results of culture tests being returned. Other, similar complaints were collected without noting the lot number of the device, making it all but impossible to track down information regarding the manufacture of the specific device.

Another finding made by investigators was that 35 reports of human hair being found in supposedly sterile medical devices had not been investigated through a Corrective and Preventive Action (CAPA) process. "The presence of foreign material in sterile packaging constitutes a significant concern," observed FDA. The agency said it needed to review the company's documents to ensure it has investigated lots posing a similar hazard.

These problems were compounded, said FDA, by the company's receipt, review and evaluation procedures. During their inspection of Atrium's facility, investigators found some reports received by the company had not been evaluated properly, and that the company did not have adequate procedures in place to collect complete information from complainants.

The company may have a chance to rectify FDA's complaints wholesale in the coming months. In April 2012-shortly before FDA's inspection-it announced it would be moving its Hudson, NH headquarters to nearby Merrimack, NH.

A call to Atrium seeking comment was not returned by the time of publication.