Atlas

Form 483

Cook Incorporated Form 483, 2024-05-08

FDA issued a Form 483 to Cook Incorporated on 2024-05-08 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Cook Incorporated · Bloomington, United States · Issued May 8, 2024

Overview

  • 1 public-safe observation is 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.

8 May 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Shannon A Gregory

Inspected site

CICook IncorporatedBloomington, United States

Inspection team

SAShannon A Gregory

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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