What will an inspector check?

An inspector at an acidified sauce operation checks whether paper and practice match: a scheduled process set by a qualified person, a process filing for every product and bottle size, a trained supervisor, batch records that prove every critical factor was met, a deviation file, a current facility registration, and a clean plant. FDA's recent warning letters to small sauce, salsa and pickle makers cite exactly those items, often several in one letter. This page reads three of them closely, lists what was found and which regulation it broke, and ends with a checklist you can use to get ready before anyone knocks.

Three recent warning letters

Each of these letters followed an FDA inspection, and each went to a maker of jarred acidified foods with a small product line.

Each letter asked for a written response within 15 working days, describing the corrections and how recurrence would be prevented, with documents [1][2][3]. The Arkansas letter warned of possible seizure, injunction or suspension of the facility's food registration [3]; the Massachusetts letter warned of seizure or injunction [1].

What the letters show inspectors look at

The paper chain from process to product

All three letters start here. The inspector asks for your scheduled process and checks who wrote it (114.83 requires "a qualified person who has expert knowledge" [4]), then checks FDA's records for a filing for each product in each container size (108.25(c)(2) [5]). Holding an FCE number without process filings fails this check [3]. So does filing one jar size and selling another [2].

Whether you follow your own process

The Iowa letter is the clearest example. The inspector compared the filed process with what was happening in the kitchen and in the records, and found a different cook hold time, different fill temperatures and no count of inverted jars [2]. Section 108.25(c)(3) requires you to process in conformity with at least the scheduled process you filed [5]. Your batch sheet is the evidence; batch records covers what it must show.

Trained supervision

The Massachusetts letter cited the absence of anyone trained at an approved school [1]. Expect to be asked for the certificate of the person supervising production, as 114.10 requires [4]. See Better Process Control School.

Deviations and what you did about them

The Iowa firm's response to the inspection did not state that deviated product had been made safe [2]. Inspectors read your separate deviation file, required by 114.100(c), and check that each entry shows the action taken and the disposition of the product [4]. See when a batch misses its limits.

Records you must let them see

Section 108.25(g) requires processing, deviation and pH records to be kept for 3 years from the date of manufacture and made available to FDA for inspection and copying during a factory inspection [5]. Section 114.100(d) requires records of initial distribution so lots can be traced [4]. Facility registration includes "an assurance that FDA will be permitted to inspect the facility" [6].

Registration status

Two of the three letters cited facility registration under section 415: one for never registering [1], one for letting the 2024 renewal lapse [3]. The 2026 renewal window runs October 1 to December 31, 2026. See food facility registration.

The plant itself

The Massachusetts letter's sanitation findings are the kind a small kitchen can fix in a week: handwashing, gloves, caps stored in a closed clean container, nothing touching jar rims, no untreated water near sealed product, pests kept out [1]. Cleaning and sanitizing covers the routine.

Labels and recall plans

The Iowa letter also cited nutrition facts and serving size errors on a pepper jam [2], and the Arkansas letter cited missing written recall procedures [3], which 108.25(e) requires [5]. Label rules are on what a hot sauce label must say.

Be ready: the inspection binder

Keep one binder, or one clearly named folder, with these in order. If you can hand it over in the first five minutes, the inspection goes better.

1. Facility registration confirmation and current renewal date; your DUNS number.
2. FCE registration confirmation.
3. For each product and size: the process authority letter, the Form 2541e confirmation and its SID.
4. Classification letters for any product you treat as an acid food or a non-acidified ferment.
5. The supervisor's Better Process Control School certificate.
6. Batch records for the last 3 years, newest first, each with pH, temperatures, times and lot code.
7. pH meter calibration log and thermometer checks.
8. The separate deviation file.
9. Distribution records showing where each lot first went.
10. Written recall procedure and contact list.
11. Supplier certificates for vinegar and other critical ingredients, as 114.100(a) asks for "suppliers' guarantees or certifications" [4].
12. Your state license and the latest state inspection report.

Walk your own kitchen once a month as if you were the inspector: read the filing, watch a batch, then check the sheet against both.

Records are where most of it lives

Nearly every finding above comes down to a record that was missing, incomplete or did not match the filing. The batch record template gives you a sheet to copy, and batch records explains each field.

References

1. U.S. Food and Drug Administration, Warning Letter to F1 Foods Inc. dba Flavor First Foods Inc., CMS 668515, March 14, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/f1-foods-inc-dba-flavor-first-foods-inc-668515-03142024
2. U.S. Food and Drug Administration, Warning Letter to Midwest Foods, LLC, May 21, 2024. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/midwest-foods-llc-677464-05212024
3. U.S. Food and Drug Administration, Warning Letter to Christopher Dale Butler, CMS 720334, January 9, 2026. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/christopher-dale-butler-720334-01092026
4. U.S. Food and Drug Administration, 21 CFR Part 114, Acidified Foods, eCFR, up to date as of October 20, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-114
5. U.S. Food and Drug Administration, 21 CFR 108.25 Acidified foods, eCFR, up to date as of October 20, 2026. https://www.ecfr.gov/current/title-21/chapter-I/subchapter-B/part-108/subpart-B/section-108.25
6. Legal Information Institute, Cornell Law School, 21 CFR 1.232 What information is required in the registration?, accessed October 22, 2026. https://www.law.cornell.edu/cfr/text/21/1.232