FDA 483 - E.M. Adams Co., Inc. - November 14, 2022

E.M. Adams Co., Inc. in Fort Pierce, FL, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish fundamental procedures for corrective and preventive actions, complaint handling, control of non-conforming product, and document control. These issues indicate a lack of basic controls necessary for compliant manufacturing operations.