Form 483

Greencore USA Inc. Form 483, 2011-04-13

FDA issued a Form 483 to Greencore USA Inc. on 2011-04-13 with 4 public-safe observations.

483· Form 483 issued4 observations

Greencore USA Inc. · Newburyport, United States · Issued April 13, 2011

Overview

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

13 Apr 2011
21 CFR 110.35(d)(5)

Shown to be effective

Cited by Nichole B Murphy, Osama A Khatib, Thomas W Nerney

13 Apr 2011
21 CFR 110.80(a)(1)

Water quality -- wash, rinse, convey food

Cited by Nichole B Murphy, Osama A Khatib, Thomas W Nerney

13 Apr 2011
21 CFR 110.80(b)(5)

Work-in-progress

Cited by Nichole B Murphy, Osama A Khatib, Thomas W Nerney

13 Apr 2011
21 CFR 123.6(b)

HACCP plan implementation

Cited by Nichole B Murphy, Osama A Khatib, Thomas W Nerney

Inspected site

GUGreencore USA Inc.Newburyport, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(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