MANUFACTURER WARNED FOR FAILING TO DOCUMENT NONCONFORMING DEVICES

Nassif Associates received a recent FDA warning letter for current good manufacturing practice violations regarding the company's cardio-card interpretation systems.

After an inspection Oct. 1218, 2006, the agency said the company did not properly document the serial numbers of three nonconforming devices that were returned and retested.

Nassif also did not document its investigation of the cause of the nonconformity or an analysis of device quality data, according to the Dec. 8 warning letter, posted recently to the FDA website.

Nassif did not return a request for comment by press time. The warning letter can be viewed at www.fda.gov/foi/warning_letters/g6178d.pdf (http://www.fda.gov/foi/warning_letters/g6178d.pdf).

(http://www.fdanews.com/ddl/34_2/)