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Form 483

Lineage Logistics ICM, LLC Form 483, 2014-07-28

FDA issued a Form 483 to Lineage Logistics ICM, LLC on 2014-07-28 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Lineage Logistics ICM, LLC · Coppell, United States · Issued July 28, 2014

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.

28 Jul 2014
21 CFR 123.6(c)(3)

Critical limits

Cited by Casey L Hamblin

28 Jul 2014
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Casey L Hamblin

28 Jul 2014
21 CFR 123.7(d)

Corrective action documentation

Cited by Casey L Hamblin

28 Jul 2014
21 CFR 123.8(a)(3)(i)

Monitoring record review adequacy

Cited by Casey L Hamblin

Inspected site

LLLineage Logistics ICM, LLCCoppell, United States

Inspection team

CLCasey L Hamblin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.7(d)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)Cited 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