Atlas

Form 483

Artifex Solutions LLC Form 483, 2018-06-07

FDA issued a Form 483 to Artifex Solutions LLC on 2018-06-07 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Artifex Solutions LLC · San Juan, United States · Issued June 7, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

7 Jun 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Nydia E Colon

7 Jun 2018
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Nydia E Colon

7 Jun 2018
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Nydia E Colon

Inspected site

ASArtifex Solutions LLCSan Juan, United States

Inspection team

NENydia E Colon

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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