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Form 483

Battle Creek Equipment Co. Form 483, 2018-10-11

FDA issued a Form 483 to Battle Creek Equipment Co. on 2018-10-11 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Battle Creek Equipment Co. · Fremont, United States · Issued October 11, 2018

Overview

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

Inspectional observations

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

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

Inspected site

BCBattle Creek Equipment Co.Fremont, United States

Inspection team

SQSuyang Qin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 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