Atlas

Form 483

Helmer Scientific Inc. Form 483, 2017-07-31

FDA issued a Form 483 to Helmer Scientific Inc. on 2017-07-31 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Helmer Scientific Inc. · Noblesville, United States · Issued July 31, 2017

Overview

  • 6 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.

31 Jul 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Joseph R Strelnik

31 Jul 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Joseph R Strelnik

31 Jul 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Joseph R Strelnik

31 Jul 2017
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Joseph R Strelnik

31 Jul 2017
21 CFR 820.90(b)(2)

Product rework procedures, Lack of or inadequate procedures

Cited by Joseph R Strelnik

Inspected site

HSHelmer Scientific Inc.Noblesville, United States

Inspection team

JRJoseph R Strelnik

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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