Form 483

Icrest International LLC Form 483, 2017-08-16

FDA issued a Form 483 to Icrest International LLC on 2017-08-16 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Icrest International LLC · El Segundo, United States · Issued August 16, 2017

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

16 Aug 2017
21 CFR 1.504(d)

Document review entity's hazard analysis

Cited by John R Myung

16 Aug 2017
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by John R Myung

16 Aug 2017
21 CFR 1.505(b)

Supplier approval - document

Cited by John R Myung

16 Aug 2017
21 CFR 1.506(b)

Supplier verification - establish written procedures

Cited by John R Myung

16 Aug 2017
21 CFR 1.506(d)(1)(i)

Verification activity assurance

Cited by John R Myung

Inspected site

IIIcrest International LLCEl Segundo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(d)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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