AFIA Update as CGMP Inspections Continue for Large and Small-sized Firms

The following update was received this week from AFIA regarding FSMA inspections. While it is difficult to get an exact count, it appears about two dozen inspections have occurred in CFD member states as of December 22, 2017. We can expect this to increase in 2018.

“CGMP Inspections Continue for Large and Small-sized Firms

The American Feed Industry Association obtained data through a Freedom of Information Act request, which indicates that state and/or federal inspectors conducted 192 current good manufacturing practice (CGMP) inspections in 35 different states between Jan. 1 and Dec. 22, 2017. More than 50 percent of the inspections occurred in Georgia, California, Iowa, New York, Minnesota, Texas and Wisconsin.

The majority of inspections (64 percent) occurred at feed manufacturers or integrator feed facilities. Ingredient suppliers, renderers, distributors and facilities classified as “other” also received inspections during the same time frame.

AFIA has gathered and compiled feedback on the inspector focus areas and what facility personnel should expect. In general, inspectors do a walk-thru evaluation of the entire facility. Their questions are mostly geared toward preventive controls qualified individual (PCQI) and qualified individual (QI) training and documentation, but they have also been interested to know more about the facility’s pest control and labeling of containers and trash receptacles. There have been a few instances where inspectors asked for documents that the Food Safety Modernization Act doesn’t entitle them to view.

Across the 192 inspections, 12 facilities received a form 483 (“Notice of Adverse Findings”). Of the 12 forms issued, six were Voluntary Action Indicated (VAI or minor issues) and the other half were classified as No Action Indicated (NAI) or were not classified. There were no failed inspections of Official Action Indicated (OAI). Issues related to pest control and housekeeping were mentioned on most of the 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 feed manufacturing 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 do apply to feed establishments under the FSMA CGMPs.”

Used with permission from AFIA