Surviving an FDA Inspection

June 18,2018 08:17 PM By James Flynn

The FDA Net Goes Global

The US FSMA (Food Safety Modernization Act) means that food importing businesses in the USA are subject to FDA Inspection for the first time.


Food manufacturing companies, based in the USA, may already be familiar with this, but there are others, such as importers/brokers and many foreign suppliers, who have never been required to be inspected by the FDA before. For them, the prospect of an FDA inspector turning up unannounced causes uncertainty and comes with some trepidation. The FSVP (Foreign Supplier Verification Program) requirement now brings thousands of USA-based importers and agents, as well as foreign companies, under the scrutiny of the FDA.


Practical Advice on Inspections

In this article, we will highlight what to expect during your inspection and help you avoid common problems. We will also give you some tips on how you can prepare and what you should do on the day of the inspection. We will give you practical advice based on years of being a food safety inspector and knowing what they look for, as well as being on the receiving end of many inspections too.


Be Prepared, Be Fearless

The FDA Inspectors, sometimes called the ‘food safety police’, are one of the enforcement arms of US government when it comes to food safety regulation in food manufacturing and importing. They have the power to carry out unannounced inspections at any time, for any reason, and they often do. An FDA inspection that goes wrong can result in the infamous 483 warning letter (which has a time period to rectify all issues identified) or, depending on the findings, the inspection may result in product recall and/or prosecution. During the inspection, the FDA is well known for being thorough, carrying out extensive environmental swabbing (“Swabathon”) and taking chemical and other samples. They will also perform rigorous documentation checks, but those who are well prepared and who are implementing food safety practices properly, have little to fear.


What to Expect

During the inspection, the inspector(s) will ask for your Food Safety Plan, which may take the form of a HACCP or HARPC plan. They will review this in detail to ensure that you are actually doing what you say you are doing in the Plan and that it meets the requirements. This will include checking the records of monitoring, verification and validation activities and reviewing microbiological and other test records. The inspector will want to understand who wrote and approved the Food Safety Plan and the credentials and experience of those involved, so you must have these documented, including training records.  The Plan must be signed and dated by the owner, operator or agent in charge of the facility when it is first completed and whenever it is modified.


What the FDA Will Want To See
The FDA will spend a significant amount of time looking at your record keeping, including production schedules, ingredients purchased, supplier approvals and labelling of products. They will especially be interested in allergens and how they are stored, handled and controlled. Through all of this, the FDA will want to see management commitment to food safety, as this is a fundamental cultural requirement of food safety. Management competence will also pay a major role. Overall, they are interested in what the food safety risks are and assessing if they are being managed effectively and in-line with the legal requirements.

Common Inspection Problems

One of the problems that may occur at inspection time is the 24 hr rule. There is a requirement that you provide the inspector with supplier and product safety information within a 24 hr time period. In addition, all records must be kept for a minimum of 2 years and they will look back for that length of time. This means that speed of access to information is critical and good systems are key to this. Another common issue is a general lack of audit preparedness. It stands to reason that if you don’t carry out regular internal and supplier audits in your business then you are likely to be vulnerable, simply because you have no internal scrutiny. It is vital that you have a robust internal audit program and supplier audit program to ensure that you are maintaining high standards. This is one of the most important ways to prepare for unannounced audits, it keeps people on their toes and reduces your risk of unexpected problems, costs, and consequences, such as prosecution or closure.


Things to Watch Out For

The FDA will already know about your food safety record before they visit you, so be prepared to defend your corrective actions if there has been a chequered food safety history. One area that you may wish to be aware of is samples of food for micro testing. Once you have the results, do not retain the samples.  You are required to keep the results, but if you also keep the samples then the FDA could test these, and even if they are past the stated shelf life, they can be used to mandate a product recall, which could be costly.


Food Importers

For food importers, FSVP and FDA inspections will be new and a little intimidating and while they may not be subject to the same environmental scrutiny on site, their facilities and products being imported will be sampled and tested at the port of entry. FDA is likely to carry out the same, or greater, level of scrutiny on supplier approval processes and food safety plans of suppliers to the importer as they would in a food factory, so it’s important to be prepared.


PCQI’s

One of the first aspects of business is to have the right people. Preparing for an FDA inspection is no different. You will need one or more PCQI’s (Preventive Controls Qualified Individual(s)) on site with direct food safety experience in the products you make, buy and sell. The PCQI’s should be leaders in a food safety team.  PCQI’s can be external consultants, which can be important in smaller food companies and importers where the resources may not exist to spare someone to be trained or to have the experience to cover the range of products imported.


Internal Audit Program

Using your internal audit program, you should check that your food safety systems are documented and staff trained in their use. You must also ensure that the required food safety tasks are performed when, how, where and by whom you say they are. The best approach is to do small, random internal audits every week. You will also need to stay up to date with legislation and what is going on with your suppliers, as ignorance is no defense. Hoping for the best is NOT an option.


How to Handle Inspection Day

FDA food safety inspections can last several days, even a week or more, so it is important to be aware of this and plan for the disruption it may cause to Management staff and resources. On the first day of an unannounced FDA inspection, you will need a robust communication plan with the rest of your business so they can be alerted. Think ‘phone tree’ or ‘email blast’. The purpose of this is not to hide anything, it’s to get people prepared to cooperate. Identify key staff that have access to the kind of information and records the FDA will need to see and ensure that those staff members are available, or that their deputies can step in. Do not panic, do be honest and cooperative. On arrival, make the FDA inspectors comfortable and establish their agenda to understand why they are inspecting you, this will help in your preparation. Ask if the inspection is routine or are they interested in something more specific?


FDA Inspectors are Human Too

Get a great start with the FDA inspector by making arrangements for the inspector and, in particular, involve senior management at the start of the inspection and ensure that they are present at the close-out meeting to discuss any actions arising. Don’t be afraid to ask for clarification at any time, FDA inspectors usually come from industry so they have probably been in your shoes and understand your concerns. They are also helpful and can give great advice, as they are usually very experienced food safety practitioners with a lot of experience so don’t try to hide anything from them. This will only serve to get them more focused on problem areas.


If you can achieve all of the above, the FDA inspector may not quite become your new friend, but he or she will not be on your case and that can only be a good thing.


Watch the webinar below and get key hints and tips on surviving and FDA inspection and also find out how 3iVerify can help you with this.

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