Form 483

WWF Operating Company LLC Form 483, 2009-10-30

FDA issued a Form 483 to WWF Operating Company LLC on 2009-10-30 with 10 public-safe observations.

483· Form 483 issued10 observations

WWF Operating Company LLC · Mount Crawford, United States · Issued October 30, 2009

Overview

  • 10 public-safe observations are available for this inspection.
  • 9 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

30 Oct 2009
21 CFR 120.6(b)

Sanitation monitoring

Cited by Brian R Yaun, Carrie L Doupnik

30 Oct 2009
21 CFR 120.8(a)

HACCP plan - location and type of juice

Cited by Brian R Yaun, Carrie L Doupnik

30 Oct 2009
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Brian R Yaun, Carrie L Doupnik

30 Oct 2009
21 CFR 120.8(b)(3)

HACCP plan - critical limits not listed or not adequate

Cited by Brian R Yaun, Carrie L Doupnik

30 Oct 2009
21 CFR 120.10(c)

Corrective action documentation

Cited by Brian R Yaun, Carrie L Doupnik

Inspected site

WOWWF Operating Company LLCMount Crawford, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.8(a)Cited across public-safe Form 483 observations2x
21 CFR 120.10(c)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)(iv)(A)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 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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