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Form 483

Hitachi America, Ltd., Power Systems Division Form 483, 2020-03-09

FDA issued a Form 483 to Hitachi America, Ltd., Power Systems Division on 2020-03-09 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Hitachi America, Ltd., Power Systems Division · White Plains, United States · Issued March 9, 2020

Overview

  • 6 public-safe observations are available for this inspection.
  • 2 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.

9 Mar 2020
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Gregson A Joseph

9 Mar 2020
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Gregson A Joseph

9 Mar 2020
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Gregson A Joseph

9 Mar 2020
21 CFR 820.198(e)

Records of complaint investigation

Cited by Gregson A Joseph

9 Mar 2020
21 CFR 820.198(e)

Records of complaint investigation

Cited by Gregson A Joseph

Inspected site

HAHitachi America, Ltd., Power Systems DivisionWhite Plains, United States

Inspection team

GAGregson A Joseph

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations3x
21 CFR 820.198(e)Cited across public-safe Form 483 observations3x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF, 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