Atlas

Form 483

Cook Incorporated Form 483, 2018-06-14

FDA issued a Form 483 to Cook Incorporated on 2018-06-14 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Cook Incorporated · Bloomington, United States · Issued June 14, 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.

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Debara R Reese

14 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Debara R Reese

Inspected site

CICook IncorporatedBloomington, United States

Inspection team

DRDebara R Reese

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)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