Atlas

Form 483

Neo Dental Chemical Products Co., Ltd. Form 483, 2018-03-27

FDA issued a Form 483 to Neo Dental Chemical Products Co., Ltd. on 2018-03-27 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Neo Dental Chemical Products Co., Ltd. · Shibuya, Japan · Issued March 27, 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.

27 Mar 2018
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Sargum C Sood

27 Mar 2018
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Sargum C Sood

27 Mar 2018
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sargum C Sood

27 Mar 2018
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Sargum C Sood

Inspected site

NDNeo Dental Chemical Products Co., Ltd.Shibuya, Japan

Inspection team

SCSargum C Sood

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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