Written by: Gary Huddleston | December 9, 2020
While the ongoing coronavirus pandemic has brought a screeching halt to most of the Food and Drug Administration’s routine inspection activity, now is a good time to think about and prepare for your next inspection when they resume. The FDA has not yet ramped up to its normal level of Food Safety Modernization Act (FSMA) inspections, but has set an aggressive plan for fiscal year 2021.
The FDA set a goal of completing 754 Current Good Manufacturing Practice (CGMP) inspections next year. It plans for the states with contracts to complete 684 of the CGMP inspections while the agency plans on completing 70. The 2021 goal for Hazard Analysis/Preventive Controls (HA/PC) inspections is 560. Since there are not as many states that have contracts with the FDA to conduct the HA/PC inspections, the FDA plans on completing 385, with states completing 175. The plan is for 30 of the HA/PC inspections to be conducted at foreign companies. The agency also stated that its goal for Foreign Supplier Verification Program inspections is 100 and Sanitary Transportation is 85 or less, respectively.
A CGMP inspection is primarily a walk-through of your facility with the inspector observing the compliance to subpart B of the animal food regulation (21 CFR part 507). A good way to prepare for a CGMP inspection is to review FDA Guidance for Industry #235. The guidance is a good, practical explanation of the requirements covered in subpart B. One of the most helpful parts of the guidance is the self-assessment tool in Appendix B. This tool provides an excellent checklist to help facilities assess their compliance to the CGMP requirements.
A HA/PC inspection is a more comprehensive review of a facility’s compliance to the remaining parts of the FSMA animal food regulation. The food safety plan, including a hazard analysis, will be thoroughly reviewed. Be prepared to explain your plan as well as provide proof that it is being followed. If you have any preventive controls in your plan, you should be prepared to show the required supporting records. If you are using facility standard operation procedures or other prerequisite programs as justification for not needing a preventive control, you may be asked to demonstrate how these procedures and programs work. This may necessitate showing some documents and records that are outside of the food safety plan. Be prepared to demonstrate how your food safety system prevents the hazards identified in you hazard analysis from making it through to your finished products.
Now is also a good time to review your company policies and procedures that pertain to inspections. You should always check the inspector’s credentials and review the FDA Form 482 – Notice of Inspection. Before beginning, be sure you understand the full scope of the inspection. Know what documents and records that you are allowed to show the inspector. Be familiar with your company policies on copying records and taking photos. You should have a thorough understanding of the requirements of the regulations and how your food safety plan meets those requirements. Do not be hesitant to explain your understanding of the regulations and even suggest reading them together if the inspector has a different interpretation. The AFIA has materials that can assist members in these areas – reach out if you need a copy.
Don’t look at an inspection as a bad thing. Look at it as an opportunity to learn and share your facility’s food safety story. Your inspection will go smoother if you are cordial, respectful and resist getting defensive. Most inspectors have a true interest in their jobs and can be very helpful if you listen with an open mind. When you are properly prepared, an inspection is your time to shine by showing how well your food safety system is working.