Atlas

FDA-Inspected Site

Battle Creek Equipment Co.

9 FDA inspections are on record for Battle Creek Equipment Co. in Fremont, United States.

483· Form 483 issued

Fremont, United States · Last updated July 9, 2026

Overview

  • 9 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2018-10-11.

At a glance

Inspections

9

Form 483s

8

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Oct 2018 – 11 Oct 2018Medical Devices & Rad Health483View 483 →
15 May 2017 – 31 May 2017Medical Devices & Rad Health483View 483 →
25 Jan 2016 – 10 Feb 2016Medical Devices & Rad Health483View 483 →
27 Jan 2015 – 12 Feb 2015Medical Devices & Rad HealthWLView 483 →
29 Jul 2013 – 1 Aug 2013Medical Devices & Rad Health483On file
13 Sep 2012Not recorded483On file
1 Mar 2011Not recorded483View 483 →
16 Jan 2009Not recorded483View 483 →
12 Nov 2003Not recordedClean

Observations on record

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

11 Oct 2018
21 CFR 820.30(c)

Design input - Lack of or inadequate procedures

Cited by Suyang Qin

11 Oct 2018
21 CFR 820.30(c)

Design input - Lack of or inadequate procedures

Cited by Suyang Qin

31 May 2017
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Suyang Qin

31 May 2017
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Suyang Qin

31 May 2017
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Suyang Qin

Investigators

FDA investigators tied to this site in the record.

Suyang Qin3 insp.
Vesa Vuniqi1 insp.
Bleta Vuniqi1 insp.
Brian J Mundo1 insp.
Anthony R Petriella1 insp.
Eric S Pittman1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations5x
21 CFR 820.20(c)Cited across public-safe Form 483 observations5x
21 CFR 820.90(a)Cited across public-safe Form 483 observations5x
21 CFR 820.80(e)Cited across public-safe Form 483 observations4x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 820.184Cited across public-safe Form 483 observations3x
21 CFR 820.30(g)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.198(b)Cited across public-safe Form 483 observations2x
21 CFR 820.30(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(c)Cited across public-safe Form 483 observations2x
21 CFR 820.70(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(b)Cited across public-safe Form 483 observations2x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(i)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Battle Creek Equipment Co.'s 8 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