Atlas

Form 483

Gendron Inc. Form 483, 2009-09-11

FDA issued a Form 483 to Gendron Inc. on 2009-09-11 with 3 public-safe observations.

483· Form 483 issued3 observations

Gendron Inc. · Bryan, United States · Issued September 11, 2009

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.

11 Sep 2009
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Rosanna M Goodrich

11 Sep 2009
21 CFR 820.40(a)

Document review, approval documentation

Cited by Rosanna M Goodrich

11 Sep 2009
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Rosanna M Goodrich

Inspected site

GIGendron Inc.Bryan, United States

Inspection team

RMRosanna M Goodrich

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.40(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