Senior Director Tara Lin Couch, Ph.D. shared Own Label Distributor (OLD) responsibilities in a recent article published in Technoscienze – AgroFOOD Industry HI Tech. Regardless of whether an OLD is domestic or international, the FDA is clear that the OLD is responsible for compliance with the regulatory requirements in 21 CFR 111, she says. “The development of critical OLD processes should include procedures such as qualification of OLD contractors; demonstration that the quality unit is fulfilling obligations of finished product specifications; a complaint system for evaluating all reported consumer concerns for the identification and reporting of Serious Adverse Events (SAEs) to FDA; and change control processes to ensure revisions are tracked and monitored.”
Posted in EAS in Action, Foods and tagged Tara Lin Couch.