FDA-Inspected Site

Abbott Laboratories

41 FDA inspections are on record for Abbott Laboratories in Sturgis, United States.

Clean· No action indicated

Sturgis, United States · Last updated July 9, 2026

Overview

  • 41 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-12.

At a glance

Inspections

41

Form 483s

5

EIRs

8

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Mar 2026 – 12 Mar 2026Foods & CosmeticsClean
8 Sep 2025 – 25 Sep 2025Foods & CosmeticsClean
8 Sep 2025 – 10 Sep 2025Foods & CosmeticsClean
11 Mar 2025 – 4 Apr 2025Foods & CosmeticsClean
15 Apr 2024 – 21 May 2024Foods & CosmeticsClean
21 Nov 2023 – 19 Dec 2023Foods & CosmeticsClean
2 Oct 2023 – 18 Oct 2023Foods & CosmeticsClean
2 May 2023 – 12 Jun 2023Foods & CosmeticsClean
14 Nov 2022 – 16 Dec 2022Foods & Cosmetics483View 483 →
11 Oct 2022 – 3 Nov 2022Foods & CosmeticsClean
28 Sep 2022 – 7 Oct 2022Foods & CosmeticsClean
8 Aug 2022 – 23 Sep 2022Foods & CosmeticsClean

Observations on record

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

16 Dec 2022
21 CFR 106.10(b)(1)

Personnel - clean outer garments, protective apparel

Cited by Dariusz Galezowski, Elizabeth P Mayer, Danny Tuntevski, Matthew R Buenconsejo, John N Woodall, Logan M Ebeling, Brittany A Mckenzie, Vera M Anderson, Roshni J Patel

16 Dec 2022
21 CFR 106.55(a)

System of process controls to prevent adulteration

Cited by Dariusz Galezowski, Elizabeth P Mayer, Danny Tuntevski, Matthew R Buenconsejo, John N Woodall, Logan M Ebeling, Brittany A Mckenzie, Vera M Anderson, Roshni J Patel

18 Mar 2022
21 CFR 106.100(k)(2)

Complaint investigation - hazard determination

Cited by Elizabeth P Mayer, Danny Tuntevski, Liliya V Bubiy, Daniel B Arrecis, Alexandra A Carrico, Ana E Morales, John N Woodall, Rohn R Robertson, Christi L Bellmore, Nicholas E Boyd, Brittany A Mckenzie, Adam M True

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 106.20(a)Cited across public-safe Form 483 observations3x
21 CFR 106.10(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 106.10(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 106.30(d)Cited across public-safe Form 483 observations2x
21 CFR 106.30(e)(5)Cited across public-safe Form 483 observations2x
21 CFR 106.30(g)Cited across public-safe Form 483 observations2x
21 CFR 106.55(a)Cited across public-safe Form 483 observations2x
21 CFR 106.55(c)Cited across public-safe Form 483 observations2x
21 CFR 106.100(k)Cited across public-safe Form 483 observations1x
21 CFR 106.100(k)(2)Cited across public-safe Form 483 observations1x
21 CFR 106.30(b)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Abbott Laboratories' 5 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