FDA 483 - Highland Park Hospital - August 01, 2019

An FDA inspection of Highland Park Hospital Blood Bank in Highland Park, IL, revealed a significant failure to maintain equipment used in the processing, storage, and distribution of blood and blood products. Specifically, the facility did not follow manufacturer's instructions for scheduled cleaning and maintenance of freezers, refrigerators, and plasma thawing systems. This indicates a lapse in critical equipment upkeep that could impact product quality and safety.