FDA Seeks Volunteers to Participate in Rollout of Observation and Corrective Action Report Portal
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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.
FDA’s OCAR workgroup developed the CAR and is phasing in the voluntary industry portal with collaborative and reciprocal capabilities. Specifically, the portal will allow firms to view their CAR, submit corrective actions, upload supporting evidence and/or documentation, and submit associated comments. FDA’s assessment of those corrections will transmitted to firms through the portal once FDA’s assessment of the corrective actions for the inspection is complete.
Request for Phase I Participants
During the closing meeting of a qualifying inspection with observations documented (FDA Form 483 items and/or discussion items), domestic human and animal food facilities will be offered the opportunity to participate in Phase 1 of the industry portal. Interested firms must notify FDA of their interest, either during the inspection, or within five business days after the inspection closes.
Phase 1 will be limited to approximately one dozen firms that meet selection criteria. After Phase 1 is complete, the industry portal will be made available to all human and animal food facilities.
A user guide for the OCAR industry portal can be accessed through the FDA website. Questions about program eligibility, and requests for more information can be directed to OCARFAQs@fda.hhs.gov.
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