At the Food Safety Preventive Controls Alliance conference that took place on October 17 and 18 in Burr Ridge, Illinois, Glenn Bass, director of the Office of Food and Feed Operations in FDA’s Office of Regulatory Affairs, detailed how FDA has evolved its approach to inspections since the pandemic.
“We have become more dedicated to training inspectors,” Bass began. “Every year we do a training needs assessment and we know that there are differences in how inspectors do their job. And we are increasing the training opportunities for all.” Bass pointed out that Course FD254, Preventive Controls for Human Food Regulators, has been attended by more than 550 FDA and 490 state regulators.
Staff development has focused more on on-the-job experience. “People in the field learn from hands-on training,” said Bass. FDA has created OJE Preventive Control “coaches,” who communicate tips to the federal and state inspectors and help them develop “systems thinking.” The coaches provide feedback to supervisors, who work with inspectors to improve inspections.
A Jump in Human Food Inspections
Bass detailed inspection activity during the Ask the Expert session. Inspections flatlined during the pandemic but are now above 2019 levels. FDA is no longer pre-informing manufacturers that they are coming to inspect as they did during the pandemic.
Fiscal year 2023 inspections (unofficial due to the close of the fiscal year on September 30) are as follows:
Modernized cGMP’s Human Food Domestic: 4,415
Modernized cGMP’s Human Food Foreign: 999
Modernized cGMP’s Human Food State: 5,060
Preventive Control Human Food Domestic: 409
Preventive Controls Human Food Foreign: 184
Preventive Controls Human Food State: 591
FDA also started doing Intentional Adulteration inspections, with 233 domestic and 482 foreign.
For the Full Scope Domestic Human Food Inspections, FDA recorded 164 NAI (No Action Indicated), 163 VAI (Voluntary Action Indicated), and 31 OAI (Official Action Indicated). The top problem was Pest Control. Results for the Foreign Full Scope were 80 NAI, 77 VAI, and 66 OAI.
Continuing Struggle with FSVP
The FSVP update was presented by Lorie S. Hannappel, safety officer, division of import operations, Office of Regulatory Affairs. “Implementation of FSVP has been an exciting roller coaster ride,” she said.
In fiscal year 2023, there were 1,059 FSVP inspections, well under the goal of 1,850. The results were 491 NAI, 548 VAI, and 20 OAI. FDA’s goal for 2024 is 2,000 FSVP inspections.
The top citation was Failure to Develop FSVP, accounting for 35 percent of citations. The other top citations included:
Evaluation – performance, risk
Verification activity before import, periodically
Approved supplier procedures – importer established
Hazard analysis: biological, chemical physical
Hazard analysis written
Supplier verification – establish written procedures
Verification activity assurance
Supplier approval – document
Verification activity frequency
65 Warning Letters were issued in fiscal 2023.
With more than 53 percent of importers requiring either voluntary or official action, compliance with FSVP is far from complete.
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