Atlas

Form 483

Panasonic Kitchen Appliances Form 483, 2017-05-15

FDA issued a Form 483 to Panasonic Kitchen Appliances on 2017-05-15 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Panasonic Kitchen Appliances · Kobe, Japan · Issued May 15, 2017

Overview

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

Inspectional observations

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

15 May 2017
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Michael P Sweeney

Inspected site

PKPanasonic Kitchen AppliancesKobe, Japan

Inspection team

GMGregory M Bessette
MPMichael P Sweeney

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, 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