Form 483

Grimmway Enterprises Inc. Form 483, 2010-08-19

FDA issued a Form 483 to Grimmway Enterprises Inc. on 2010-08-19 with 7 public-safe observations.

483· Form 483 issued7 observations

Grimmway Enterprises Inc. · Arvin, United States · Issued August 19, 2010

Overview

  • 7 public-safe observations are available for this inspection.
  • 6 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.

19 Aug 2010
21 CFR 110.35(d)(5)

Safe and adequate for use

Cited by Helen J Hamaoka

19 Aug 2010
21 CFR 120.8(b)(4)

HACCP plan - monitoring procedures - none listed

Cited by Helen J Hamaoka

19 Aug 2010
21 CFR 120.10(a)

Corrective action - predetermined plan

Cited by Helen J Hamaoka

19 Aug 2010
21 CFR 120.10(a)

Corrective action - predetermined plan inadequate

Cited by Helen J Hamaoka

19 Aug 2010
21 CFR 120.11(a)(1)

Verification activities - minimum

Cited by Helen J Hamaoka

Inspected site

GEGrimmway Enterprises Inc.Arvin, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.10(a)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(b)Cited across public-safe Form 483 observations1x
21 CFR 120.24(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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