In the most recent session of the monthly FSMA Friday live updates with TAG and SafetyChain Software, TAG Food Safety Director Eric Edmunds provided an overview of FDA’s 483 in the Age of FSMA. Following is a Q&A on key points from the webinar. What is 483?
Essentially, it is the notification that an inspector leaves with a facility following an inspection that provides a listing of the observations, discussion points of the inspection. This form is not intended to be all-inclusive, but to include the major issues observed. FDA inspectors also include a narrative report that is used internally at FDA. FDA’s definition is “An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.” So, what happens when you receive a 483? If you receive a 483, you need to review it and respond with your conducted or planned corrective action. FDA adds this to the narrative of the 483 then determines if the facility’s response solves the issue. It is important that this response be sent quickly and accurately. If you have questions, a call can sometimes be made to discuss it, but, either way, you need to be sure to respond within the timeline given. If FDA doesn’t see the response as solving the issue – or if no response is received – you can likely expect to receive a warning letter Who can see 483s?
All 483s are public information, so – technically – anyone can see a 483. They are not always very accessible, and there may be a fee for access, but 483s also can be requested through the Freedom of Information Act (FOIA). FDA also has a web page on which it posts the most commonly requested 483s. Two of these, which Edmunds recommended, are: ORA FOIA Electronic Reading Room FDA Data Dashboard What are the most common regulatory citations on 483s?
Following are the seven most common regulatory citations for Preventive Controls Rule for Human Food in 2018 at domestic facilities – many of which are basic violations that companies should have in place by now. Some are GMPs, but FDA is really starting to focus on PCs. 21 CFR 117.130(a)(1): Conducting a hazard analysis. This could include incomplete analysis or complete lack of one. It is essential because it is the first step of the new regulation. 21 CFR 117.126(a)(1): Preparing and implementing written food safety plan. As the second step of Preventive Controls, it is the second most common violation. 21 CFR 117.40 Equipment and utensils (e.g., not clean, not easily accessible) 21 CFR 117.35(d) Sanitation of food-contact surfaces. This is a very basic GMP. 21 CFR 117.145(a) Written procedures for monitoring. It is critical that these are written as required by the PC Rule. 21 CFR 117.150(a)(1) Corrective action procedures. These can be difficult for many, but they are very important to have as a “go to” if an issue occurs. 21 CFR 117.165(a) Verification of preventive controls. A key part of this is having a PCQI to verify that the processes and preventive controls are met. (For the full regulations and their requirements, see slides 12-15 of the FSMA Fridays August 2018 session – FDA 483s: Trends in the Age of FSMA.) What other trends are we seeing in the Age of FSMA? In addition to the PC 483s, TAG is seeing: An evolution from “Educate before we regulate” to “Education while we regulate.” While FDA does seem to still be educating, it is definitely enforcing the FSMA rules. But it also seems that companies are addressing the issues well because we have not seen any substantial increase in warning letters. The trend is a slow movement into enforcement which we expect to continue, with FDA expectations that companies understand and implement rules. That said, as previously noted, we have seen a shift in 483 violations from GMPs to Preventive Controls We’re also seeing FDA moving from education to enforcement of the FSVP rule. Similar to the PC rule, a failure to have written supplier program or FSVP will cause a 483 to be issued. We do expect to continue to see an increase in the number of FSVP investigations. The 483 violation trends seem to be similar for foreign facilities as for domestic. That is, having no hazard analysis, written PCs or written verification, and inadequate sanitation are key. What is largely different is that pest exclusion, inadequate facilities (e.g., handwashing sinks, plumbing, etc.) are high on the list of violations for foreign facilities. As to the Produce Rule. FDA Commissioner of Foods and Drugs Dr. Scott Gottlieb sent a letter to the state departments of agriculture and national association noting that the states will be doing most of the produce inspections. Up to 47 states have been granted money for implementation and training. FDA will still step in on for-cause inspections. FDA has been working with the National Association of State Departments of Agriculture to create a new form that will replace the usual 483 for covered produce farms. So, for the Produce Rule it is unlikely that 483s will be used for inspection observations, rather, there will be a new form that addresses the same issues as a 483 for facilities. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at: www.AchesonGroup.com