Hatch Product Development LLC – FDA 483, Dec 11, 2025

Hatch Product Development LLC, a contract manufacturer and distributor of class II medical devices, was cited with five observations during an FDA inspection. The firm's quality system was found to be severely lacking, with inadequate procedures for corrective and preventive actions, complaint handling, Medical Device Reporting, control of nonconforming material, and finished device acceptance. These deficiencies indicate a systemic failure to maintain proper controls over critical aspects of medical device manufacturing and distribution.