The FDA has enhanced the process for documenting corrections made by a firm in response to FDA observation(s) during inspections at human and animal food facilities. Corrective actions taken by the firm in response to observations will be documented in the Corrective Action Report (CAR). Each correction will be described and linked to the subject observation(s), whether the observation was listed on the FDA Form 483 or was relayed as a discussion item.

The Observation and Corrective Action Report (OCAR) program was established to develop a new framework to facilitate a mobile, electronic workforce and improve the planning, communication, efficiency and consistency of inspection data collection, analysis, and reporting. As part of this program, the FDA 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 the FDA via the Industry Portal. 

Once available, this voluntary and confidential Industry Portal will provide two-way communication capability that allows firms to view the CAR, submit corrective actions and upload supporting evidence and/or documentation. The FDA’s assessment of those corrections will be viewable and accessible to firms through the Industry Portal once the assessment of the corrective actions for the inspection is complete.

Potential Benefits in Joining the Program

• Efficient communication with the FDA on Corrective Action(s) taken to correct observations made during FDA inspections.
• Improved public health protection by prompt and direct communication addressing food safety issues

Phase 1 Participation Limit

Phase 1 will be limited to a few firms that meet the selection criteria.  The FDA is currently accepting volunteers for Phase 1.  After Phase 1 is complete, the Industry Portal will be made available to all Human and Animal Food Facilities.

How to Volunteer for the Program

For Phase 1, eligible firms will be offered the opportunity to participate in the program during inspections. To participate firms must notify the local FDA office within 5 business days after the inspection.

Contact Us

For questions about program eligibility and more information, please contact OCARFAQs@fda.hhs.gov. 

Guides 

• Industry Participation Handout (PDF: 245 KB)
• System User Guide