Observation and Corrective Action Report (OCAR) Industry Portal
FDA Now in Phase II of the Food Safety Modernization Act (FSMA) OCAR Industry Portal for Human and Animal Food Facilities to Submit Corrective Actions
Background Information
FDA has enhanced the process for human and animal food facilities to submit documentation of voluntary corrective actions they have taken to address observation(s) made by FDA during inspections at their facilities. Corrective actions taken by the firm in response to observations will be documented in the 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 [1]), a description of the correction(s) made by the firm to address the observation, and any supporting documentation submitted by the firm.
The Observation and Corrective Action Report (OCAR) program was established as part of FDA’s agency-wide modernization and enhanced technologies initiative. FDA’s OCAR workgroup developed the CAR and is phasing in a voluntary Industry Portal with collaborative/reciprocal capabilities that allows firms to view the CAR and interact with FDA in a secure and private manner via the Industry Portal.
The Industry Portal will allow firms to view the 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 Industry Portal once FDA’s assessment of the corrective actions for the inspection is complete.
Phase I – FDA Soliciting Volunteers
FDA has completed soliciting volunteers for Phase 1 of the Industry Portal. We are now in Phase II.
Phase II – Evaluation and Enhancements
We are now in Phase II of the Industry Portal rollout, focusing on evaluating feedback received from the Phase 1 participants and assessing whether enhancements are needed to the system before making the Industry Portal and the CAR available for all food facilities. During this phase, we have solicited user feedback and will implement any final enhancements necessary to optimize the portal’s functionality. These enhancements will help ensure a seamless, modernized and efficient process for submitting corrective actions to the FDA through the industry portal. The expanded rollout to all human and animal food firms is expected in calendar year 2025.
Please revisit this page for further updates and announcements regarding the Industry Portal as we continue to enhance this critical system for food safety and regulatory compliance.
Contact Us
For questions about program eligibility and more information, please contact OCARFAQs@fda.hhs.gov.