Implementing FSMA In an Almost-Post-COVID-19 World

FDA inspections of manufacturing facilities to check compliance with the Preventive Controls for Human Foods (PCHF) rules of the Food Safety Modernization Act slowed significantly in 2020 due to COVID travel restrictions. But they accelerated in 2021 and are expected to jump in 2022 as FDA steps up enforcement.

“The pandemic forced us to constrain our inspections for Preventive Controls,” said Glenn Bass, program deputy director, Office of Regulatory Affairs, FDA, during last week’s Food Safety Preventive Controls Alliance conference.

“We found new ways to supplement on-site inspections,” he added. “We learned a lot that will help us as we move forward with in-person inspections in the future.”

After a four-month hiatus, on-site inspections were resumed in July 2020. To protect the health of inspectors, facilities were characterized as Red (no inspection), Yellow (cautionary) or Green (okay to inspect) based on the infection rates within their county. A facility’s compliance history was also a contributing factor.

Departing from precedent, FDA began to pre-announce inspections, giving companies a five-day notice before arriving on-site. That has now been reduced to one day, and Bass anticipates that surprise inspections will resume in the near future.

Remote Regulatory Assessments

In response to pandemic challenges, FDA started a program called Remote Regulatory Assessments. An RRA is a request for a remote review of the records that a firm is required to maintain for FDA’s review under normal circumstances. RRAs are strictly voluntary, and there is no penalty for opting out of an RRA.

The benefits of an RRA for human food facilities include:

• Potentially decreasing future on-site inspection time because a portion of the record review will already be completed.

• The ability to assess a facility’s compliance with certain regulations by FDA outside of an inspection, which allows facilities to make corrective actions prior to their next on-site inspection.

FDA is analyzing the success of this program to determine how it can be utilized in conjunction with future on-site inspections.

A 75 Percent Increase in PCHF Inspections

FDA is planning to do many more Full Inspections for the PCHF rule but is lagging behind in the targeted number due to COVID and staffing challenges, according to Bass.

In fiscal 2020 (October 1, 2019 – September 30, 2020), FDA conducted 436 PCHF inspections and state agencies conducted 316. Only 98 foreign facilities were inspected by FDA offices outside of the U.S., down from 212 in the previous fiscal year.

In contrast, there were 626 FDA inspections and 695 state inspections in fiscal 2021, an increase of 75 percent. That number is expected to jump substantially in fiscal 2022, which began on October 1, 2021.

Related: FDA Continues Salmonella Traceback InvestigationFDA Issues Challenge to Develop Affordable Traceability Tools

by: Perry Wings
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