FDA 483 - MycoScience Labs, LLC - February 15, 2024

MycoScience Labs, LLC, a medical device contract manufacturer in Willington, CT, was cited for seven observations during an FDA inspection. The inspection revealed significant deficiencies in process validation, control of non-conforming products, corrective and preventive actions, environmental controls, process controls, supplier management, and device history records. These issues indicate a lack of robust quality system procedures impacting the manufacturing of medical devices.