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Form 483

CK Management, Inc. Form 483, 2014-04-10

FDA issued a Form 483 to CK Management, Inc. on 2014-04-10 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

CK Management, Inc. · Plano, United States · Issued April 10, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

10 Apr 2014
21 CFR 111.55

Production, process controls - implement

Cited by Jamie M Bumpas

10 Apr 2014
21 CFR 111.570(b)(1)

Written procedures - product complaint; review, investigate

Cited by Jamie M Bumpas

Inspected site

CMCK Management, Inc.Plano, United States

Inspection team

JMJamie M Bumpas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.55Cited across public-safe Form 483 observations1x
21 CFR 111.570(b)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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