Atlas

Form 483

G.C. Hanford Manufacturing Company Form 483, 2011-03-04

FDA issued a Form 483 to G.C. Hanford Manufacturing Company on 2011-03-04 with 5 public-safe observations.

483· Form 483 issued5 observations

G.C. Hanford Manufacturing Company · Syracuse, United States · Issued March 4, 2011

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

4 Mar 2011
21 CFR 211.56(b)

Written sanitation procedures not followed

Cited by Kenneth G Klobus

4 Mar 2011
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Kenneth G Klobus

4 Mar 2011
21 CFR 211.165(c)

Sampling and testing plans not followed

Cited by Kenneth G Klobus

4 Mar 2011
21 CFR 211.182

Specific information required in individual logs

Cited by Kenneth G Klobus

4 Mar 2011
21 CFR 211.188(b)(5)

In-process and laboratory control results

Cited by Kenneth G Klobus

Inspected site

GHG.C. Hanford Manufacturing CompanySyracuse, United States

Inspection team

KGKenneth G Klobus

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.56(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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