Atlas

Form 483

Fujifilm Optics Co. Ltd. Mito Form 483, 2014-01-30

FDA issued a Form 483 to Fujifilm Optics Co. Ltd. Mito on 2014-01-30 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

Fujifilm Optics Co. Ltd. Mito · Hitachiomiya, Japan · Issued January 30, 2014

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

30 Jan 2014
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Catherine J Laufmann

30 Jan 2014
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Catherine J Laufmann

30 Jan 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Catherine J Laufmann

30 Jan 2014
21 CFR 820.184

DHR content

Cited by Catherine J Laufmann

30 Jan 2014
21 CFR 820.198(e)

Records of complaint investigation

Cited by Catherine J Laufmann

Inspected site

FOFujifilm Optics Co. Ltd. MitoHitachiomiya, Japan

Inspection team

CJCatherine J Laufmann

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 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited 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 5 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