FDA updates standards designed to help direct resources
The US Food and Drug Administration (FDA) said updates to the Manufactured Food Regulatory Program Standards (MFRPS) include newly defined terms, sections and appendices.
MFRPS establish a basis for measuring and improving the performance of prevention, intervention and response of manufactured food regulatory programs.
They are designed to help federal and state agencies better direct activities toward reducing foodborne illness hazards.
The regulatory program standards are ten points designed to protect the public from foodborne illness and injury.
These include staff training, inspection, quality assurance, food defense preparedness and response, foodborne illness and incident investigation, enforcement, education and outreach, resource management, laboratory resources and program assessment.
“At their core, the standards support the development of a robust, quality management system for how FDA and our regulatory partners help ensure uniform and consistent oversight of regulated industry,” said Steven M. Solomon, deputy associate commissioner for regulatory affairs at FDA.
AIB service
Meanwhile, AIB International has launched its FDA Preparedness Inspection to help US companies, as well as those exporting to the country, measure regulatory readiness before an inspector arrives.
The one-day inspection simulates an FDA inspection as FSMA's preventive control rules have come into force for some companies.
Food and beverage manufacturers, warehouses, and distribution centers can find out if they are prepared and if employees are following established policies for handling regulatory inspections.
Alicia Pullings, quality compliance manager for Gonnella Baking Company, said it was confident in the level of FSMA preparedness prior to the inspection.
“The visit was unannounced to even our plant manager, which allowed us to simulate an actual FDA inspection. If anything, this experience reminded us that we need to be audit ready at all times.
“Thanks to the feedback AIB provided after our FDA Preparedness Inspection, we plan to implement a few revisions to our current programs for improved compliance.”
AIB also offers a FSMA Readiness Assessment, GMP Inspection or private FSMA training.
