483
LCC Medical Research Institute, LLCLCC Medical Research Institute, LLC – FDA 483, Sep 13, 2019
Record Details
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.
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ID · fe83161c-c6c4-432b-8a18-e37275895ff3
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