Key takeaways:
- The FDA hasn’t met its FSMA domestic or foreign inspection targets since fiscal 2018. A 2025 federal evaluation found 26% of high-risk food facilities went three straight years without an inspection.
- Walmart and Costco expect at least one audit a year, and Walmart won’t count an FDA or USDA inspection toward its requirement. For plants selling into major retail, the customer audit is the one that recurs every year, and it’s linked directly to revenue.
- Audit readiness should be part of the revenue process. Give it one owner, a current evidence pack for each major customer, a live corrective action log, and a quarterly mock audit against your biggest buyer’s checklist.
In fiscal 2023, 22,414 domestic food facilities were due for an FDA inspection under the Food Safety Modernization Act (FSMA). The FDA inspected 7,590 of them. Investigators tried and failed to get into another 3,481, and the remaining 11,343 were missed.
This shortfall has continued for years. GAO found FDA hasn’t met its domestic or foreign inspection targets since fiscal 2018.
For plants that sell into major retail, the auditor they can count on seeing every year works for a customer. That impacts what audit readiness is worth to the business. With proper execution, audit readiness protects the accounts you have and helps you secure the next one.
The FDA reaches about one in seven food facilities a year
As mandated by FSMA, the FDA should inspect every high-risk domestic facility at least once every three years and every other facility at least once every five. The agency nearly hit both marks in fiscal 2018 and 2019. Then a 35-day government shutdown and the pandemic hit, and the share of overdue high-risk facilities jumped to 40% in 2020 and 49% in 2021.
The HHS Office of Inspector General (OIG) picked up the thread in a June 2025 evaluation. Its findings on domestic inspections included:
- The FDA inspected 12,595 facilities in 2017 and 10,151 in 2023. The 2023 count covers 13.5% of the facilities on the FDA’s list, or roughly one in seven.
- The FDA didn’t inspect 26% of high-risk facilities in continuous operation from fiscal 2021 through 2023 for the full three-year window.
- Among lower-risk facilities in continuous operation from fiscal 2019 through 2023, 34% went uninspected for five years.
- Spending on inspections fell about 6%, from roughly $166 million in 2017 to $156 million in 2023.
Staffing contributes significantly to the issue, as GAO counted 432 investigators in July 2024, nearly a quarter of them eligible to retire, and it takes about two years to fully train a replacement. In its formal response to OIG, the FDA said its foods program has nearly 90 investigator positions vacant.
The FDA agreed with the recommendations in both reports, and the legal requirements don’t vanish just because the agency is behind on inspection targets. Your preventive controls, records, and recall plan have to be ready whether an investigator arrives this year or in 2030. But an FDA investigator may not be the one to test them.
Retail buyers audit every year, on their own terms
Walmart’s food safety requirements for national branded suppliers require an audit for any plant making product for Walmart or Sam’s Club, whether or not the supplier owns that plant. Suppliers must keep an annual, approved audit in place. The retailer notes that inspections by the FDA, USDA, or state and local health agencies, and audits conducted for other retailers aren’t a substitute.
Costco’s audit expectations FAQ, issued in August 2025, calls for one audit per year. Its standard GMP audit stays unannounced. After a failed audit or a critical finding, the supplier has 24 hours to notify its Costco coordinator. Costco expects the re-audit done inside 60 days of the first one.
So a plant that ships to both has an annual audit obligation to each, and Costco’s GMP audit can arrive without notice. Over the same year, the FDA reaches about one facility in seven.
A failed customer audit puts revenue at risk
FDA findings move through a regulatory process with its own steps and timelines. Customer findings move through your account. Walmart notes that failing to keep an annual, approved audit “may result in loss of business and deactivation of your vendor number.”
And Costco has a strict timeline with its 24-hour notice and 60-day re-audit window. Sixty days goes fast when the corrective action involves a capital repair, a revalidated sanitation procedure, or retraining an entire shift.
When audit prep is on the QA calendar as a once-a-year event, those deadlines turn into a scramble. Your customer’s auditor wants evidence your floor generates every day. If no one pulls it together until two weeks before the visit, the holes surface in front of the person who controls your shelf space.
Congress is weighing a bigger role for private audits
In April 2026, Rep. Michael Rulli of Ohio introduced H.R. 8431, the Third-Party Certification and Inspection Modernization Act. The bill would allow the FDA to consider results from accredited third-party audits and certifications when it analyzes risk and decides which facilities to inspect. It would also add a factor to how the FDA picks facilities: whether a plant holds certification to a third-party food safety standard that the agency has found aligned with its preventive controls rules.
The bill is with the House Energy and Commerce Committee. If a version of it becomes law, the certification and audit record you build for customers could also impact how often the FDA visits your facility.
Your audit record also works as a sales document
Retail buyers tie every supplying site to a current, approved audit. Your audit history follows you into every pitch for a new item, a new region, or a first listing. If you make product for other brands, expect their quality teams to ask for the same paperwork.
A multiyear run of clean audits, closed corrective actions, and passed unannounced visits gives a buyer fewer reasons to hesitate. That record should be viewed in the same way your sales team views a reference account. It took years to build, and one failed visit can put it in question.
Four ways to stay audit-ready between visits
1. Designate one owner for the customer audit calendar
Put every major customer’s audit cycle, scheme, and announced or unannounced status on one calendar. Choose someone with the authority to pull people and budget from production when a finding needs a quick solution.
2. Build an evidence pack for each top customer
Start with what that customer’s auditor asked for last time, such as sanitation records, environmental monitoring results, supplier approvals, allergen controls, and training sign-offs. Refresh it monthly so an unannounced visit becomes a retrieval job.
3. Keep one standing corrective action log
Record every finding from customer audits, internal audits, and regulatory visits with an owner, root cause, fix, and verification date. When a 24-hour notice countdown starts, you can report from the log rather than rebuilding the history from email.
4. Run a quarterly mock audit against your largest customer’s checklist
The certification standard decides the minimum. Your biggest buyer’s addendum or GMP checklist decides whether you keep the account, so score your mock audit the way that auditor would.
Let software keep the paper trail current
Most of what an auditor reviews is already in your plant’s data. Temperature logs, sanitation verifications, training records, and supplier certificates with expiration dates all live in systems or spreadsheets. AI tools that read those records continuously can flag a missed check or an expiring certificate the week it happens. Audit prep then becomes a review of records you’re familiar with and trust.
Invest in food safety technology where needed. But keep a person accountable for sign-off. Auditors still want to talk with the people who own the program, and software can’t explain an unverified corrective action.
For plants selling into major retail, most of the audits on this year’s calendar come from customers, and each one is tied to an account. Put an owner on that calendar this week. Then pull last year’s findings for your largest customer and check which ones are still open.
