AFIA Reminds Members of Expectations for HA/PC Inspections, Clarifies Investigator Process with FDA

Most of the feed mills that subscribe to my posts are small facilities and not currently subject to inspections of Feed safety Plans.  This article published by AFIA reminds large facilities what to inspect when FDA knocks to do a Feed Safety Plan inspection. It has valuable information you need to consider as you continue to prepare your Feed safety Plan. In the coming months you may get a CGMP inspection. Remember while the FDA is not inspecting small facility feed safety plans you are required to have one in place. I have bolder the part that i have been preaching for almost 3 years now. Please read this important information…

November 8, 2018 AFIA

“The American Feed Industry Association’s legislative and regulatory team recently held a call with the U.S. Food and Drug Administration’s Office of Regulatory Affairs (ORA) to discuss hazard analysis and preventive control inspections, which are now beginning in the animal food industry. ORA trains, directs and operates all FDA surveillance, compliance and most enforcement actions and is responsible for all field investigators.

As a reminder, AFIA encourages animal food facility personnel to fully cooperate with investigators during FSMA compliance inspections. Your facility’s animal food safety plan should be the main focal point of these inspections. It should tell your food safety story, including how your facility mitigates the risks of the hazards it has identified in its hazard analysis. It is very important that facility personnel are able to effectively communicate the details of your facility’s food safety system. For those facilities where the preventive controls qualified individual is in another office, plant personnel need to be well-informed about the plan so that they may answer any questions investigators have.

AFIA believes that the risks of almost all identified hazards can be effectively mitigated without the need for preventive controls in an animal food safety plan. Most likely, the risks will be mitigated through the use of the facility’s standard operating procedures (SOPs). Your facility should be prepared to show the investigator any SOPs used as justification for not having a preventive control. When showing the investigator the SOP, you should be able to effectively communicate how it mitigates the risks of the identified hazard and be able to prove its effectiveness.

On the topic of copying records, the ORA officials were adamant that copies or photographs should only be requested when the investigator has a valid reason, for instance, to document something the investigator saw that raised questions. If an investigator asks to copy or take a photograph without offering the reason, the facility should ask the inspector for what reason the copy/photo is requested. The ORA officials provided AFIA staff with a few examples, including if there was a finding that was an issue of public health significance or if there was an issue where the investigator was not familiar with and needed assistance from the technical assistance network within FDA’s headquarters.

AFIA appreciates the opportunity to openly discuss how the agency will conduct these inspections. We are putting a plan in place to hold quarterly discussions with the ORA officials on how the inspections are going, including any issues they are seeing at facilities. We’ll relay this information to AFIA members as we receive it to help you better prepare for your inspections. ORA is willing to meet and encouraged by our offer to keep an open dialogue.”

Reprinted with permission.