Atlas

Form 483

Mani, Inc. - Kiyohara Facility Form 483, 2013-05-23

FDA issued a Form 483 to Mani, Inc. - Kiyohara Facility on 2013-05-23 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Mani, Inc. - Kiyohara Facility · Utsunomiya, Japan · Issued May 23, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

23 May 2013
21 CFR 820.30(c)

Design input - Lack of or inadequate procedures

Cited by Eric M Padgett

23 May 2013
21 CFR 820.100(b)

Documentation

Cited by Eric M Padgett

23 May 2013
21 CFR 820.198(a)

Complaints

Cited by Eric M Padgett

Inspected site

MIMani, Inc. - Kiyohara FacilityUtsunomiya, Japan

Inspection team

EMEric M Padgett

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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