SUMMA THERAPEUTICS, LLC – FDA 483, Feb 26, 2026

SUMMA THERAPEUTICS, LLC, a medical device manufacturer in Allston, MA, was cited with eight observations on a Form 483 following an FDA inspection. The inspection revealed significant deficiencies in process validation for sterilization and sterile barrier processes, inadequate design validation, and poor control over outsourced manufacturing. Additionally, the firm failed to report a device recall to the FDA, indicating systemic issues with documented procedures and adherence to quality system requirements.