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FDA Reveals FSMA Experience at Annual Conference

Specialty Food Association

FDA has emerged from the pandemic with a renewed emphasis—and a new approach—to inspecting manufacturers for compliance with the Preventive Controls for Human Food regulations of the Food Safety Modernization Act and to inspecting importers to determine whether they are following the Foreign Supplier Verification Program.

“Our inspections are still ebbing and flowing but we are moving in the right direction,” said Glenn Bass, deputy director, human and animal food operations—west, Office of Regulatory Affairs, FDA, during last week's Food Safety Preventive Controls Alliance Annual Conference. “We continue to rethink our field activities based on what we learned during the pandemic.”

During FY2022, which runs from October 1, 2021 to September 30, 2022, there were approximately 940 full-scope PCHF inspections (FDA, 450; State, 490). This is 34 percent more than the 700 that took place in FY2021. In addition, FDA carried out 67 full-scope PCHF inspections of foreign facilities; foreign inspections continue to be significantly impacted by travel restrictions.

The following were the most common reason for citations:

1. Did not develop a food safety plan

2. Inadequate pest control

3. Inadequate sanitary operations and plant maintenance

4. Inadequate controls for processing, packing, and holding

5. Inadequate training for personnel

FDA is continuing to announce PCHF inspections in advance, to help companies prepare and reduce the amount of time that inspectors are on-site.

It's also embracing the Remote Regulatory Assessments, which were initiated during the pandemic. These are being offered to firms that have a positive inspection history and are voluntary. FDA will request and review records and have a virtual meeting with the company. RRAs do not replace on-site inspections but are a time saver for all.

Continuing Challenges with FSVP Inspections

Whereas manufacturers are mostly complying with the PCHF regulations, importers continue to struggle with the FSVP rules, according to Selina Mata, Supervisory Consumer Safety Officer, Division of Import Operations, Office of Regulatory Affairs, FDA.

FDA completed 852 FSVP inspections in FY2022, well short of its goal of 1,825. The goal for FY2023 is 1,850 FSVP inspections for importers of human food. (There are additional goals for animal food.)

More than 50 percent of the importers inspected were lacking in compliance, with 37 cited for Official Action Indicated and 401 for Voluntary Action Indicated. The top citations were:

1. Did not develop an FSVP

2. Did not evaluate the risk of the imported food

3. Did not document that an evaluation was conducted

4. Did not establish a procedure for supplier verification

5. Did not do a hazard analysis

During the pandemic, FDA did mostly remote FSVP inspections, asking for and reviewing records. These were convenient, efficient, and reduced stress for importers being inspected for the first time. Going forward, “there will be a healthy balance of remote and on-site inspections,” said Mata.

Related: Experts Discuss 'Healthy' Label Claim During FDA WebinarRogers: Many Small Businesses Unaware of FSVP Requirements