FDA 483 - Sunrise Medical Laboratories, Inc. - November 19, 2010

An FDA inspection of Sunrise Medical Laboratories, Inc. in Hicksville, NY, revealed significant deviations in their testing processes for communicable disease agents and record-keeping. The firm failed to adhere to manufacturer's instructions for various assays, potentially compromising the accuracy of donor specimen results. Additionally, critical documentation, such as incubation parameters and personnel identification, was not maintained concurrently with testing activities.