Atlas

Form 483

A G Specialty Foods Inc Form 483, 2012-09-14

FDA issued a Form 483 to A G Specialty Foods Inc on 2012-09-14 with 4 public-safe observations.

483· Form 483 issued4 observations

A G Specialty Foods Inc · Happy Valley, United States · Issued September 14, 2012

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

14 Sep 2012
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Zachary P Wachlarowicz

14 Sep 2012
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Zachary P Wachlarowicz

14 Sep 2012
21 CFR 123.8(a)(3)(i)

Monitoring record review adequacy

Cited by Zachary P Wachlarowicz

14 Sep 2012
21 CFR 123.8(b)

Verification - corrective action

Cited by Zachary P Wachlarowicz

Inspected site

AGA G Specialty Foods IncHappy Valley, United States

Inspection team

ZPZachary P Wachlarowicz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 123.8(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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