Atlas

Form 483

Flint Welding Supply Company Form 483, 2015-02-12

FDA issued a Form 483 to Flint Welding Supply Company on 2015-02-12 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Flint Welding Supply Company · Flint, United States · Issued February 12, 2015

Overview

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

Inspectional observations

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

12 Feb 2015
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Emily J Orban, Cynthia L Aycock, Cynthia Li

12 Feb 2015
21 CFR 211.166(a)

Lack of written stability program

Cited by Emily J Orban, Cynthia L Aycock, Cynthia Li

12 Feb 2015
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Emily J Orban, Cynthia L Aycock, Cynthia Li

Inspected site

FWFlint Welding Supply CompanyFlint, United States

Inspection team

EJEmily J Orban
CLCynthia L Aycock
CLCynthia Li

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)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