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Form 483

KOWA CO. LTD. CHOFU Form 483, 2018-07-05

FDA issued a Form 483 to KOWA CO. LTD. CHOFU on 2018-07-05 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

KOWA CO. LTD. CHOFU · Chofu, Japan · Issued July 5, 2018

Overview

  • 4 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.

5 Jul 2018
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Jocelyn E Massey

5 Jul 2018
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Jocelyn E Massey

5 Jul 2018
21 CFR 820.30(g)

Design validation acceptance criteria

Cited by Jocelyn E Massey

5 Jul 2018
21 CFR 820.30(g)

Design validation acceptance criteria

Cited by Jocelyn E Massey

Inspected site

KCKOWA CO. LTD. CHOFUChofu, Japan

Inspection team

JEJocelyn E Massey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 4 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