Form 483

Turbochef Technologies Inc Form 483, 2017-03-28

FDA issued a Form 483 to Turbochef Technologies Inc on 2017-03-28 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Turbochef Technologies Inc · Carrollton, United States · Issued March 28, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

28 Mar 2017
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Michael P Sweeney, Joseph C Teixeira

28 Mar 2017
21 CFR 1030.10(c)(3)(iii)

Measurements with tap water container

Cited by Gregory M Bessette, Michael P Sweeney, Joseph C Teixeira

Inspected site

TTTurbochef Technologies IncCarrollton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1010.2(c)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(iii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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