Atlas

Form 483

GC Hanford Manufacturing Company Form 483, 2019-09-27

FDA issued a Form 483 to GC Hanford Manufacturing Company on 2019-09-27 with 3 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds3 observations

GC Hanford Manufacturing Company · Syracuse, United States · Issued September 27, 2019

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.

27 Sep 2019
21 CFR 211.142

Written warehousing procedures established/followed

Cited by Sony Mathews

27 Sep 2019
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Sony Mathews

27 Sep 2019
21 CFR 211.84(e)

Rejecting When Specifications Not Met

Cited by Sony Mathews

Inspected site

GHGC Hanford Manufacturing CompanySyracuse, United States

Inspection team

SMSony Mathews

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.84(e)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