Atlas

FDA-Inspected Site

Lifecore Biomedical, LLC

17 FDA inspections are on record for Lifecore Biomedical, LLC in Chaska, United States.

483· Form 483 issued

Chaska, United States · Last updated July 9, 2026

Overview

  • 17 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-03-12.

At a glance

Inspections

17

Form 483s

7

EIRs

5

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Mar 2025 – 12 Mar 2025Human Drugs483View 483 →
11 Jan 2021 – 21 Jan 2021Medical Devices & Rad Health483View 483 →
12 Nov 2019 – 22 Nov 2019Human DrugsClean
28 Jan 2019 – 26 Feb 2019Human Drugs483View 483 →
28 Jul 2017 – 7 Aug 2017Medical Devices & Rad HealthClean
14 Feb 2017 – 2 Mar 2017Medical Devices & Rad Health483View 483 →
16 Nov 2015 – 20 Nov 2015Human Drugs483View 483 →
24 Apr 2013 – 25 Apr 2013Medical Devices & Rad HealthClean
18 Jan 2013Not recordedClean
24 Feb 2012Not recordedClean
21 Jul 2011Not recorded483View 483 →
20 Jan 2011Not recordedClean

Observations on record

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

12 Mar 2025
21 CFR 211.166(a)

Written program not followed

Cited by Roger F Zabinski, Tyler M Peterson

12 Mar 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Roger F Zabinski, Tyler M Peterson

21 Jan 2021
21 CFR 820.50(b)

Supplier notification of changes

Cited by Christina L Bigham

21 Jan 2021
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Christina L Bigham

26 Feb 2019
21 CFR 211.110(b)

In-process materials specifications testing

Cited by Ross J Grigsby, Scott A Golladay

Investigators

FDA investigators tied to this site in the record.

Ross J Grigsby2 insp.
Scott A Golladay2 insp.
Joseph D Gong2 insp.
Susan M Matthias2 insp.
April L Young2 insp.
Aaron L Dunbar2 insp.
Roger F Zabinski1 insp.
Tyler M Peterson1 insp.
Christina L Bigham1 insp.
Yoon K Oh1 insp.
Toyin B Oladimeji1 insp.
Gregory A Berg1 insp.
Marissa S Steinhagen1 insp.
Marie A Fadden1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.110(b)Cited across public-safe Form 483 observations3x
21 CFR 211.113(b)Cited across public-safe Form 483 observations3x
21 CFR 211.160(b)Cited across public-safe Form 483 observations3x
21 CFR 211.194(a)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.25(a)Cited across public-safe Form 483 observations3x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations3x
21 CFR 211.46(c)Cited across public-safe Form 483 observations3x
21 CFR 211.68(b)Cited across public-safe Form 483 observations3x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Lifecore Biomedical, LLC's 7 Form 483s

Source PDFs, 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