FDA 483 - Greenfield Global USA Inc - January 18, 2022

Greenfield Global USA Inc. in Brookfield, CT, an API repacker and manufacturer, was cited with six observations during an FDA inspection. The inspection revealed significant deficiencies in quality unit operations, including inadequate complaint investigations and a lack of proper cleaning and process validation for API manufacturing. Additionally, the firm failed to maintain appropriate controls to prevent contamination, ensure quality agreements with clients, and implement an ongoing stability testing program for its products.