FDA 483 - Centrix, Inc. - March 02, 2022

Centrix, Inc., an OTC drug manufacturer in Shelton, CT, was inspected and cited for significant deficiencies across its drug product manufacturing operations. Key issues include the absence of a formal stability testing program, inadequate control over incoming components and labeling, widespread failures to follow written procedures in production and maintenance, and a lack of documented cGMP training for employees. Many of these issues were previously observed or discussed in a 2017 FDA inspection, indicating persistent non-compliance.