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Form 483

iCRco, Inc. Form 483, 2016-09-15

FDA issued a Form 483 to iCRco, Inc. on 2016-09-15 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

iCRco, Inc. · Goleta, United States · Issued September 15, 2016

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.

15 Sep 2016
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by Sarah A Hassas

15 Sep 2016
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Sarah A Hassas

15 Sep 2016
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sarah A Hassas

15 Sep 2016
21 CFR 820.70(a)

Process control procedures, Lack of or inadequate procedures

Cited by Sarah A Hassas

Inspected site

IIiCRco, Inc.Goleta, United States

Inspection team

SASarah A Hassas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.120Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)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 4 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