Form 483

The Eggo Company Form 483, 2010-01-14

FDA issued a Form 483 to The Eggo Company on 2010-01-14 with 6 public-safe observations.

483· Form 483 issued6 observations

The Eggo Company · Rossville, United States · Issued January 14, 2010

Overview

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

Inspectional observations

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

14 Jan 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Lacey J Chessor, Whitney White, Cheryl G Scott, Kimberly Dutzek, Erica M Katherine, Jessica Stephens, Melanie L Drayton, M A Abel I, Christophe L Boulmay

14 Jan 2010
21 CFR 110.10(b)(6)

Failure to wear

Cited by Lacey J Chessor, Whitney White, Cheryl G Scott, Kimberly Dutzek, Erica M Katherine, Jessica Stephens, Melanie L Drayton, M A Abel I, Christophe L Boulmay

14 Jan 2010
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Lacey J Chessor, Whitney White, Cheryl G Scott, Kimberly Dutzek, Erica M Katherine, Jessica Stephens, Melanie L Drayton, M A Abel I, Christophe L Boulmay

14 Jan 2010
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Lacey J Chessor, Whitney White, Cheryl G Scott, Kimberly Dutzek, Erica M Katherine, Jessica Stephens, Melanie L Drayton, M A Abel I, Christophe L Boulmay

14 Jan 2010
21 CFR 110.35(d)

Failure to clean - general

Cited by Lacey J Chessor, Whitney White, Cheryl G Scott, Kimberly Dutzek, Erica M Katherine, Jessica Stephens, Melanie L Drayton, M A Abel I, Christophe L Boulmay

Inspected site

TEThe Eggo CompanyRossville, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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