Atlas

Form 483

Battle Creek Equipment Co. Form 483, 2011-03-01

FDA issued a Form 483 to Battle Creek Equipment Co. on 2011-03-01 with 4 public-safe observations.

483· Form 483 issued4 observations

Battle Creek Equipment Co. · Fremont, United States · Issued March 1, 2011

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 Mar 2011
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Anthony R Petriella

1 Mar 2011
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Anthony R Petriella

1 Mar 2011
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Anthony R Petriella

1 Mar 2011
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Anthony R Petriella

Inspected site

BCBattle Creek Equipment Co.Fremont, United States

Inspection team

ARAnthony R Petriella

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere