Atlas

Form 483

Flint Welding Supply Company Form 483, 2011-08-04

FDA issued a Form 483 to Flint Welding Supply Company on 2011-08-04 with 2 public-safe observations.

483· Form 483 issued2 observations

Flint Welding Supply Company · Flint, United States · Issued August 4, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

4 Aug 2011
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Sarah M Napier, Patsy J Domingo

4 Aug 2011
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Sarah M Napier, Patsy J Domingo

Inspected site

FWFlint Welding Supply CompanyFlint, United States

Inspection team

SMSarah M Napier
PJPatsy J Domingo

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 211.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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