Is your facility prepared for an FDA inspection, or are there gaps in your preparation? And … how do you know?
Are You Ready for an FDA Inspection? Common Gaps in Food Safety Readiness
If you feel that your facility is somewhat, but not really prepared, take heart, the majority of respondents of a poll taken during a recent TAG webinar were in the same boat: 52% stated that there were gaps in their facility’s inspection readiness or their readiness had never been assessed. Additionally, while mock inspections are one of the best ways to prepare for an FDA inspection – and to know that you are ready – 44% stated that their facility did not conduct regular mock inspections.
Although being unprepared may put you in the majority, it’s not the best majority to be in! As former FDA official/now TAG Senior Advisor Don Kautter discussed in his presentation on preparing for FDA inspections, there are ways to prepare, and “the more prepared you are, the less of a surprise you will have in front of you, and the less stress will be involved in an inspection.”
FDA Inspection Preparation Checklist: 5 Critical Areas to Review
Areas of particular focus in your preparation should include a review of your:
- Corrective actions on inspection observations made by the FDA in a previous inspection. Have these been corrected? Was the issue fixed? Are they still working as expected? An inspector will often check out these areas first, and any continued or recurring related issues will be a huge red flag.
- Food safety documentation requirements for FDA inspections. The old adage that “If it’s not documented, it didn’t happen” will be seen as fact by an inspector. Did you train your workers? Is it documented? Do you have an allergen program? Is it documented? Do you have…/Did you do…? Ensure all your documentation is complete, up to date, and easy to access.
- How to train your team for an FDA inspection. You should assign a dedicated inspection team that understands the process, greets the inspector, and holds the opening meeting; have dedicated personnel to stay with the inspector throughout the inspection; and train all personnel on how to handle themselves during an inspection.
- Ensuring FDA regulatory compliance. This one should be a given, as complying with all applicable regulations should be simply the base of your food safety practices. But if you’ve not conducted a recent review of your program against regulations, particularly any updates from the FDA, we advise that you take time to do that.
- Why food safety culture matters in FDA inspections. While there are no specific food safety culture regulations, there are regulatory expectations. FDA specifically states, “A strong food safety culture is a prerequisite to effective food safety management” – and inspectors are looking for it in your documents, procedures, training, and conversations with you and your line personnel.
Know You Are Ready for FDA through Mock Inspections
While it is important to review each of these, and all your safety practices, regularly, mock inspections are truly one of the best ways to know that you are prepared for a real inspection, as they provide a thorough look for gaps and practices or processes needing improvement that would catch an inspector’s eye.
The mock inspection can be done in-house with an experienced team, but working with an external expert enables a look at your facility through a new, impartial set of eyes to catch things that are often missed by those who see them every day. A mock inspection should include a physical walk-through inspection of the facility, as well as a thorough review of documentation. Additionally, having an unannounced mock inspection of which even your management team is unaware (except, of course, the one who set it up with the external expert) will make it all the more real, constructive, and beneficial.
The mock inspection should be viewed as a real inspection and include all aspects of an FDA inspection: pre-inspection meeting with your designated team, document review, walk-through, closing meeting, and follow-up corrective action. By uncovering – and correcting – gaps yourself, you can correct them before they become an issue or lead to a 483, warning letter, or worse.
Improve FDA Inspection Readiness with Expert Mock Inspections
If you’ve been through an FDA inspection, you know how stressful it can be and how being prepared can make a huge difference. If you’ve not had an FDA inspection, or not recently, it’s all the more important to understand what to expect and how to be prepared. With three former FDA officials and a full cadre of inspection experts on our team, TAG can work with you to customize a mock inspection for your facility, train your team, or assist in other inspection preparedness areas. Give us a call!
Summary: Mock inspections are one of the most effective ways to prepare for an FDA inspection by identifying gaps in documentation, training, and compliance before regulators arrive. By proactively addressing issues and strengthening food safety culture, companies can reduce risk and improve inspection outcomes.
