Form 483

Artivion, Inc Form 483, 2014-03-19

FDA issued a Form 483 to Artivion, Inc on 2014-03-19 with 17 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health17 observations

Artivion, Inc · Kennesaw, United States · Issued March 19, 2014

Overview

17 public-safe observations are available for this inspection.
17 structured CFR citations are represented.
6 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

19 Mar 2014

21 CFR 820.25(a)

Personnel

Cited by Cordelia J Brammer, Dawn M Braswell, Kimberly C Delk-Brooks, Tammara A Stephens, Melanie M Walker, Dellarese L Herbert

19 Mar 2014

21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Cordelia J Brammer, Dawn M Braswell, Kimberly C Delk-Brooks, Tammara A Stephens, Melanie M Walker, Dellarese L Herbert

19 Mar 2014

21 CFR 820.40

Lack of procedures, or not maintained

Cited by Cordelia J Brammer, Dawn M Braswell, Kimberly C Delk-Brooks, Tammara A Stephens, Melanie M Walker, Dellarese L Herbert

19 Mar 2014

21 CFR 820.70(b)

Production and Process Change Procedures, lack of or Inad.

Cited by Cordelia J Brammer, Dawn M Braswell, Kimberly C Delk-Brooks, Tammara A Stephens, Melanie M Walker, Dellarese L Herbert

19 Mar 2014

21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Cordelia J Brammer, Dawn M Braswell, Kimberly C Delk-Brooks, Tammara A Stephens, Melanie M Walker, Dellarese L Herbert

Inspected site

AIArtivion, IncKennesaw, United States

Inspection team

CJCordelia J Brammer

DMDawn M Braswell

KCKimberly C Delk-Brooks

TATammara A Stephens

MMMelanie M Walker

DLDellarese L Herbert

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 1271.260(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.100(b)	Cited across public-safe Form 483 observations	1x
21 CFR 820.140	Cited across public-safe Form 483 observations	1x
21 CFR 820.150	Cited across public-safe Form 483 observations	1x
21 CFR 820.198(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.198(c)	Cited across public-safe Form 483 observations	1x
21 CFR 820.25(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.250(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.30(g)	Cited across public-safe Form 483 observations	1x
21 CFR 820.40	Cited across public-safe Form 483 observations	1x
21 CFR 820.70(b)	Cited across public-safe Form 483 observations	1x
21 CFR 820.70(c)	Cited across public-safe Form 483 observations	1x
21 CFR 820.70(g)(1)	Cited across public-safe Form 483 observations	1x
21 CFR 820.75(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.80(b)	Cited across public-safe Form 483 observations	1x
21 CFR 820.80(d)	Cited across public-safe Form 483 observations	1x
21 CFR 820.90(a)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 17 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