FDA Now Soliciting Volunteers to Participate in Phase I of the FSMA OCAR Industry Portal for Human and Animal Food Processing Facilities to Submit Corrective Actions
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), 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 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.
Request for Phase I Participants
During the closing meeting of a qualifying inspection, eligible firms that meet the following selection criteria will be offered the opportunity to participate in Phase 1 of the Industry Portal:
- Domestic human/animal food facility
- Inspection conducted with observations documented (FDA Form-483 items and/or discussion items)
Interested firms must notify FDA of their interest, either during the inspection, or within 5 business days after the inspection closes.
Potential Benefits in Joining the Program
- Modernized and efficient communication with FDA on Corrective Action(s) taken to correct observations made during FDA inspections.
- Improved public health protection by prompt and direct communication with firms regarding their corrective actions
Phase 1 Participation Limit
- Phase 1 will be limited to about a dozen firms that meet the selection criteria. After Phase 1 is complete, the Industry Portal will be made available to all Human and Animal Food Facilities.
How can I volunteer for the Program?
- Interested firms can notify FDA of their interest during the inspection, or
- Interested firms can notify the local FDA division office within 5 business days after the inspection closes.
For questions about program eligibility and more information, please contact OCARFAQs@fda.hhs.gov.