FDA 483 - Organogenesis, Inc. - June 08, 2018

An FDA inspection of Organogenesis, Inc. in Canton, MA, a medical device manufacturer, revealed a significant issue regarding the establishment of requirements for suppliers and contractors. Specifically, the firm failed to adequately define the tests conducted by its contract laboratory for received tissues, leading to inconsistencies in documentation. This indicates a moderate severity issue related to quality control and supplier management.