FDA 483 - Impact Fulfillment Services - August 01, 2025

During an FDA inspection conducted from July 29 to August 1, 2025, Ryder Integrated Logistics, Inc., an OTC repackager located in Burlington, North Carolina, received an FDA Form 483. The inspection revealed significant observations regarding the company's quality system. A primary issue identified was that the responsibilities and procedures for the Quality Control Unit were not adequately documented or consistently followed. Specifically, the Quality Unit failed to initiate corrective and preventative actions (CAPAs) as required by its own standard operating procedure, SOP-IFS-06-001. A critical example cited was the absence of a CAPA, deviation, or investigation after condensate was observed dripping near an active product repackaging line. This deficiency indicates a potential lapse in maintaining product quality and safety during manufacturing operations. As an FDA 483 document, these are formal inspectional observations, not a final determination of compliance. However, they signal potential violations of regulatory standards. Ryder Integrated Logistics, Inc. is expected to respond to these observations by implementing corrective actions and providing documentation to the FDA to address the identified quality system deficiencies and ensure adherence to good manufacturing practices.