Same Goal, Different Jobs: Responding to Form 483's

Written by: Gary Huddleston   |   March 13, 2024

CVM, FDA, 483's

I am an avid college football fan. When watching my beloved Tennessee Volunteers play, I must admit that a lot of my frustration is usually aimed at the officials, which, a lot of the time, is probably a little biased and unfair. At the end of the day, college football fans realize that as much as we like to criticize the officials, we need them to help ensure the fairest outcome of games.  

Similarly, in the animal food industry, while we sometimes get frustrated with the Food and Drug Administration (FDA) and state inspectors before, during and after inspections, we recognize that they are the “officials” of our beloved  industry. They are necessary to help ensure a safe supply of animal food. Safe animal food is the primary goal of our industry as well as the inspectors. Same goal, just different jobs. 

In conversations with the FDA Center for Veterinary Medicine, the AFIA recently received some great advice on how firms should appropriately respond to an FDA Form 483 – Inspectional Observations (483), meaning WHAT. An insufficient response to a 483 could lead to an FDA Warning Letter. You must respond in writing to the 483 within 15 business days. The goal of your response letter should be to outline your corrective actions and your implementation plan to address the observations documented on the 483. Your response to a 483 must demonstrate and show the effectiveness of the corrective actions as well as your implementation plan. The issues documented in post-Food Safety Modernization Act (FSMA) 483’s tend to require facilities more time to correct, so multiple responses to a 483 may now be required to effectively demonstrate effectiveness and implementation. 

To assist facilities, the current advice we can offer is to be thorough in your response and follow up with additional information to tell your story. AFIA members can find additional information on this topic on our website. What other tips do you have in dealing with inspections materials? Let us hear them below or feel free to reach out.