FDA 483 - Lohxa LLC - April 30, 2025

Lohxa LLC, a drug manufacturer and repacker in North Oxford, MA, received a Form 483 with serious observations related to environmental controls, equipment maintenance, and quality control. The firm failed to ensure adequate air handling, properly clean and maintain equipment, conduct necessary microbiological testing, and thoroughly investigate batch deviations. These issues indicate significant deficiencies in their manufacturing processes, posing a high risk of contamination and compromising drug product quality and safety.