FDA 483 - Lohxa, LLC - July 19, 2021

Lohxa, LLC, a drug repacker in Worcester, MA, received four observations during an FDA inspection, with three being repeat findings. The firm was cited for significant deficiencies including a lack of validated repacking processes, use of unqualified equipment, failure to conduct annual product reviews, and incomplete batch production records. These issues indicate a systemic lack of control over critical manufacturing and quality assurance operations.