Welcome to the first issue of Audit-Ready Monthly. Each month I'll pull the FDA and USDA actions that matter most to food, beverage, and dietary supplement manufacturers, and turn them into a short list of things you can check in your own operation. No legal jargon, just what I'd look at if I walked your floor tomorrow.

1. Three importers warned for missing FSVPs

On September 28, FDA warning letters to three food importers in Massachusetts and New Jersey were made public. The common finding: no Foreign Supplier Verification Program (FSVP) for the foods they imported.

FSVP is one of the most cited FSMA rules, and it catches smaller importers and brand owners who assume their foreign supplier "handles food safety."

Check this month:

• Do you have a written FSVP for every food you import, by food and by supplier?
• Is there a documented hazard analysis and supplier evaluation behind each one?
• Is your FSVP Qualified Individual named, trained, and signing off on the records?

2. Two Texas beverage companies cited for acidified food violations

Close to home for us in DFW. On September 21, FDA warning letters to two Texas beverage companies were published. Findings included not registering as a food canning establishment, not filing scheduled processes, and not adequately monitoring pasteurization and pH. FDA also found disease-related claims that made some products unapproved new drugs.

Functional beverages are booming, and many startups do not realize a low-acid or acidified beverage falls under 21 CFR 108, 113, and 114.

Check this month:

• Has a process authority reviewed your product and process, and is the scheduled process filed with FDA?
• Is your facility registered as a food canning establishment (FCE) if required?
• Are pH and thermal process records reviewed and signed by a trained supervisor?
• Does any label, website, or social post claim the product treats, cures, or prevents a disease?

3. Nearly half of supplement plants were cited

ConsumerLab published FDA inspection data obtained through a FOIA request: in fiscal year 2025, FDA inspected about 800 dietary supplement facilities, and 49.1% received a noncompliance finding. International sites fared worse than U.S. sites.

The most common 21 CFR 111 findings are not exotic. They are the basics:

• No product specifications for identity, purity, strength, and composition
• No written quality control procedures
• Incomplete batch production records

Check this month: Pull one finished product and trace it back. Can you show the specification, the test result that proves each spec was met, and a complete batch record? If any link is missing, that is a 483 waiting to happen.

4. Outbreaks to learn from

• Sprouts and Salmonella. FDA and CDC linked 32 illnesses in six western states to broccoli sprouts from one Idaho grower.
• Raw milk cheese and E. coli O26. 13 illnesses, 8 hospitalizations, and 3 cases of HUS across nine states were tied to raw milk cheddar and jack cheeses. The firm recalled the same day FDA contacted it.

The lesson for every manufacturer: your environmental monitoring and supplier approval programs are only as good as your response when something is found. Know who makes the hold and recall call, and practice a mock recall at least once a year.

5. On the calendar

• Food facility registration renewal is open October 1 to December 31, 2026. Every FDA-registered food facility must renew in even-numbered years. A lapsed registration can be treated as expired, so put it on this quarter's to-do list.
• FDA released the 2026 Food Code on September 17. It mainly affects retail and foodservice, but worth a look if you sell to those channels.
• FSMA 204 traceability compliance is now July 20, 2028. That sounds far off, but Key Data Element and Critical Tracking Event records take time to build with your suppliers and customers. Start the gap assessment now.

Tool of the month: FDA 483 Response Checklist

If you receive a 483, the clock starts when the inspection ends. FDA considers responses received within 15 business days before deciding whether to issue a Warning Letter. I put together a free two-page checklist that walks through the closeout meeting, root cause and CAPA, and writing the response. Get it free on our Resources page.

Korbin Black, M.S., PCQI, Six Sigma Black Belt. Founder, Kompliance Food Safety Consulting. General information only, not legal advice.