Posted On: February 13, 2025

Navigating FDA Inspections: Tips for a Smooth Process

FDA inspections can be stressful.

For one, you never have enough time to prepare. If you’re lucky, you’ll get a few weeks’ notice, but you could end up with as little as five days. Additionally, the stakes are high. A failed FDA inspection can have expensive consequences for a food business.

Below, we’ll help you prepare for an FDA inspection by discussing their importance, the consequences of non-compliance, and a few practical tips for preparation after you’re told an inspection is coming.

Why Are FDA Inspections Important?

Food safety regulations are critically important to protecting public safety in a complicated food supply chain like ours. They protect the general public – especially its most vulnerable populations – from potentially deadly foodborne illness.

Food safety inspections are a key part of monitoring and enforcing compliance with these regulations. FDA inspections, in particular, involve monitoring parts of the food supply chain that are completely hidden from your average citizen. This includes food manufacturers, processors, packers, importers, distributors, wholesalers, and brokers.

For the subject of an FDA inspection, the process is important because FDA compliance is critical to the viability and success of the business. Non-compliance can be disastrous for a food business, not just because of potential FDA penalties and sanctions, but because it also affects a business’s reputation and future prospects.

Consequences of Non-Compliance with FDA Regulations

If non-compliance is discovered during an FDA inspection, there are many potential consequences. It depends on the type of business as well as the nature and extent of the violation.

More minor infractions typically result in warning letters that lay out ways to bring facilities back into FDA compliance. If the organization responds with corrective actions right away, this may be as far as the process goes.

When necessary, the FDA has other enforcement options in its toolbox to protect the public from unsafe products. It can issue a food recall if it’s concerned that products on the market present a public health concern, and it can issue a product seizure or import refusal to prevent unsafe products from getting to market in the first place. It can request a court injunction to force a compliance action or to stop actions that violate FDA compliance. There are also a variety of ways to stop an organization from doing a certain type of business, like embargos, suspension of registration, debarment, and disqualification.

Regardless of other actions, violations can be punished with Civil Monetary Penalties (CMPs) ranging from $10,000 to $20,000 per violation.

When actions rise to the level of criminal conduct, the FDA can pursue criminal prosecution. Criminal penalties can include fines of up to $15,000 per violation, up to $1 million per proceeding, and/or up to 10 years of imprisonment.

Common FDA Violations

Food production and manufacturing businesses have to follow a host of FDA regulations, from food safety and cross-contamination prevention to marketing and labeling requirements.

Common FDA violations include pest control problems, failure to follow Current Good Manufacturing Practices (cGMPs), failures in hazard analysis and control, and failure to have a Foreign Supplier Verification Program (FSVP) plan.

Do Restaurants Have FDA Inspections?

You may have noticed a distinct omission from our list of businesses subject to food safety inspections by the FDA: retail businesses like grocery stores and food service establishments.

FDA regulations and recommendations do apply to food service establishments, but FDA inspectors already have their hands full with food manufacturers and distributors.

So instead of directly conducting restaurant FDA inspections, the FDA relies on state and local health departments. They provide these agencies with food safety recommendations, training, technical assistance, and program support. Local health departments typically adopt FDA compliance through the U.S. Food Code and enforce them through the local food safety inspection process.

How To Prepare for an FDA Inspection

If you’re a food business subject to direct FDA inspection, you probably won’t have time to fix serious FDA compliance problems in the weeks or days before the inspection happens.

That’s why the best long-term strategy for a smooth FDA inspection process is to create a culture of FDA compliance in your organization. This involves a daily effort to ensure that FDA regulations are followed in every area of the business.

That said, you should take specific steps to prepare for an FDA inspection after you receive notice. Ideally, as part of your long-term planning, you’ll have assembled a detailed and facility-specific FDA inspection checklist that you can use to make sure everything is ship-shape.

Even if you don’t have a checklist to use, there are three main steps you can take ahead of time to ensure a smooth inspection day.

#1: Know What to Expect

If you’ve never personally participated in an FDA inspection before, it’s a good idea to know what to expect ahead of time.

When your FDA investigators arrive, they’ll introduce themselves and show their credentials. Then their first order of business will be to “verify and/or gather administrative information.” In other words, they’ll look at paperwork and ask questions about the business overall, then review operational information for select products.

Next will be the walkthrough of the facility. They’ll observe processes, procedures, and employee practices. They’ll probably review written procedures and records as they go, and they may speak with employees to learn how closely those documents are being followed.

After the walkthrough, investigators will ask for additional records on specific areas of the operation that interest them.

At the end of the inspection, they’ll provide you with a written list of “significant inspectional observations” and may discuss any smaller problems they saw. This will be your chance to ask questions and discuss the corrective actions to take moving forward.

You’ll be required to submit a written response about all corrective actions within 15 working days of the end of the inspection.

#2: Line up Paperwork and Subject Matter Experts

As you see, paperwork will be front and center in your FDA inspection, so you need to gather and organize all documentation as soon as you learn that an inspection is imminent.

It’s also a good idea to line up subject matter experts (SMEs) capable of answering questions in various knowledge arenas and ensure that they’ll be there on the day. If possible, arrange for a backup SME in each area just in case your primary choice is unavailable. If you have enough lead-up time, practice interviews and help all SMEs and backups prepare.

#3: Review Past Corrective Actions

You absolutely must review past inspections and their results.

If you’ve ever been dinged for public health concerns, you’ll be expected to speak about corrective actions you’ve taken. Make sure relevant paperwork is available and that both management and SMEs are prepared to speak on these topics as needed.

Investigators will pay special attention to verifying these corrective actions during their walkthrough, so you should prioritize making sure these changes are being followed to the letter.

After the Inspection: Respond to Observations with an Actionable Plan

After the inspection has occurred, it’s important to meet the 15-day deadline in your written response to any observations. You want your response to be robust and thorough in the form of a Corrective and Preventative Action (CAPA) Plan.