Update from AFIA on FSMA Inspections

The following information was provided by AFIA on 3/13/19. Used with permission…

The Food and Drug Administration had a busy year in 2018 conducting inspections for the current good manufacturing practice (CGMP) and the hazard analysis and risk-based preventive controls portions of the Food Safety Modernization Act (FSMA) regulations. In this update, the American Feed Industry Association shares the latest data received through a Freedom of Information Act request.

Current Good Manufacturing Practice Inspections

In 2018, the data indicates that state and/or federal inspectors performed and/or completed 622 CGMP inspections in 47 different states, one U.S. territory (Puerto Rico) and four countries (Canada, Mexico, India and Indonesia). 

The majority of CGMP inspections (58 percent) occurred at feed manufacturers or integrated feed facilities. Ingredient suppliers, renderers, distributors and facilities classified as “other” also received inspections during the same time frame. 

Across the 622 inspections, 28 facilities received a FDA Form 483 (“Notice of Inspectional Observations”). Of the 28 forms issued, 14 were Voluntary Action Indicated (VAI, or minor issues), five were classified as No Action Indicated (NAI) and eight were not classified. One facility failed inspection, receiving an Official Action Indicated (OAI) notice. Issues related to pest control and housekeeping were mentioned on most of the FDA Form 483s, with the most common examples being spilled feed, bird droppings and nests, live and dead rodents, cat excrement and the presence of roaches. Although a facility may consider many of these observations irrelevant, the FDA considers them serious. There are no sanitation standards that specify the number of rodents or droppings that can be present at a feed facility, but AFIA cautions that numerous dead rodents or other sanitary issues may draw FDA’s ire.¬†General sanitation standards apply to animal food establishments under the FSMA CGMPs

Hazard Analysis and Risk-Based Preventive Controls Inspections

Inspections for large-sized animal food facilities (i.e., those firms with more than 500 full-time equivalent employees) on the hazard analysis and risk-based preventive controls regulations began in late 2018. These large-sized firms have been required to be in compliance with the regulations since September 2017, however, the FDA delayed inspections while it trained investigators, allowing firms more time to gather documentation under the system. 

Through the FOIA request, AFIA has learned of seven hazard analysis and risk-based preventive controls inspections that occurred in 2018. The inspections were held in four states at feed manufacturing, integrated feed facilities and pet food facilities. From the seven inspections, six facilities received a FDA Form 483, which is a very high rate. It is believed this high rate of observations can be attributed to the fact that the FDA purposefully sought out these facilities as they may have had recent animal food safety incidents. As industry interprets receiving a FDA Form 483 as very serious, AFIA is in communication with FDA officials regarding this action to help ensure the reasons the agency issued a FDA Form 483 are truly adverse findings versus a simple method of documenting the findings from the inspection.