FDA 483 - Lyne Laboratories, Inc. - October 21, 2022

Lyne Laboratories, Inc. in Brockton, MA, was inspected by the FDA, resulting in seven observations related to significant deficiencies in quality control, production and process controls, laboratory practices, facility maintenance, and equipment cleaning. Repeat observations from previous inspections indicate persistent issues with complaint investigations and quality unit adherence to procedures. The findings suggest a systemic lack of adherence to established procedures and proper facility/equipment maintenance, which could impact drug product quality.