Atlas

Form 483

Horiba Instruments, Inc dba Horiba Medical Form 483, 2013-05-16

FDA issued a Form 483 to Horiba Instruments, Inc dba Horiba Medical on 2013-05-16 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Horiba Instruments, Inc dba Horiba Medical · Irvine, United States · Issued May 16, 2013

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

16 May 2013
21 CFR 803.40(a)

Report of death, injury by marketed device

Cited by Angela Shepas, Charles L Larson

16 May 2013
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Angela Shepas, Charles L Larson

16 May 2013
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Angela Shepas, Charles L Larson

Inspected site

HIHoriba Instruments, Inc dba Horiba MedicalIrvine, United States

Inspection team

ASAngela Shepas
CLCharles L Larson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)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