FDA-Inspected Site

Balchem, LLC

5 FDA inspections are on record for Balchem, LLC in Sleepy Eye, United States.

Clean· No action indicated

Sleepy Eye, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-04.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Feb 2026 – 4 Feb 2026Foods & CosmeticsClean
3 Mar 2022 – 4 Mar 2022Foods & Cosmetics483View 483 →
10 Aug 2017 – 11 Aug 2017Foods & CosmeticsClean
8 Jul 2014Foods & Cosmetics483On file
12 Jun 2012Not recorded483On file

Observations on record

Form 483 observations cited at this site, most recent first.

4 Mar 2022
21 CFR 117.80(c)

Manufacturing, processing, packing, holding - Controls

Cited by Julie Woodberry

Investigators

FDA investigators tied to this site in the record.

State Agency2 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Balchem, LLC's 3 Form 483s

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat