FDA 483 - LCC Medical Research Institute, LLC - September 13, 2019

An FDA inspection of LCC Medical Research Institute, LLC. in Miami, FL, conducted from September 10-13, 2019, identified a significant issue regarding the storage of retention samples. The firm failed to properly store these samples on-site or with an independent third-party, instead compromising their integrity by initially shipping them to the test article packager/labeler. This practice raises concerns about the proper handling and control of critical study materials.