Atlas

Form 483

Aaren Scientific Inc. Form 483, 2014-01-08

FDA issued a Form 483 to Aaren Scientific Inc. on 2014-01-08 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Aaren Scientific Inc. · Ontario, United States · Issued January 8, 2014

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

8 Jan 2014
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Sonya L Karsik

Inspected site

ASAaren Scientific Inc.Ontario, United States

Inspection team

SLSonya L Karsik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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