FDA 483 - Enemeez, LLC dba Summit Pharmaceuticals - February 12, 2026

Eneemez LLC, a manufacturer in Phoenix, AZ, was inspected and received a Form 483 with five observations indicating significant deficiencies in its quality control unit and manufacturing processes. The observations highlight failures in quality oversight, inadequate investigations, improper product testing, deficient raw material testing, and incomplete cleaning validations, suggesting a moderate to severe level of non-compliance with cGMP regulations.