The U.S. Food and Drug Administration (FDA) is soliciting volunteers to participate in the first phase of the rollout of the new Observation and Corrective Action Report (OCAR) portal. OCAR, a Food Safety Modernization Act (FSMA) initiative, is a program that enables human and animal food facilities to submit documentation of voluntary corrective actions they have taken to address regulatory non-compliances noted by the agency during facility inspections.
After submission of corrective actions to OCAR by human and animal food facilities, the actions will be documented in a firm’s Corrective Action Report (CAR). The CAR will contain all observation(s) made by FDA during inspections (FDA Form 483 items and any discussion items), a description of the correction(s) made by the firm to address the observation, and any supporting documentation submitted by the firm.