FDA-Inspected Site

Sioux Biochemical Inc

6 FDA inspections are on record for Sioux Biochemical Inc in Sioux Center, United States.

Clean· No action indicated

Sioux Center, United States · Last updated August 15, 2026

Overview

  • 6 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-25.

At a glance

Inspections

6

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Feb 2026 – 25 Feb 2026Foods & CosmeticsClean
9 Jun 2015 – 16 Jun 2015Animal Drugs & Feeds483View 483 →
19 May 2010Not recorded483View 483 →
29 Jul 2008Not recordedClean
13 Jan 2005Not recordedClean
3 Oct 2003Not recordedClean

Observations on record

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

16 Jun 2015
21 CFR 211.113(b)

Validation lacking for sterile drug products

Cited by Joseph R Lambert

16 Jun 2015
21 CFR 211.137(a)

Expiration date lacking

Cited by Joseph R Lambert

16 Jun 2015
21 CFR 211.165(a)

Testing and release for distribution

Cited by Joseph R Lambert

16 Jun 2015
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Joseph R Lambert

16 Jun 2015
21 CFR 211.182

Written records kept in individual logs

Cited by Joseph R Lambert

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.137(a)Cited across public-safe Form 483 observations2x
21 CFR 211.165(a)Cited across public-safe Form 483 observations2x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations2x
21 CFR 211.182Cited across public-safe Form 483 observations2x
21 CFR 211.186(a)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)Cited across public-safe Form 483 observations2x
21 CFR 211.188(b)(11)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.80(a)Cited across public-safe Form 483 observations2x
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(b)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(10)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sioux Biochemical Inc's 2 Form 483s

Verbatim observations and 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