Form 483

Fresh Pasta Delights, Inc. Form 483, 2014-02-18

FDA issued a Form 483 to Fresh Pasta Delights, Inc. on 2014-02-18 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Fresh Pasta Delights, Inc. · Dallas, United States · Issued February 18, 2014

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 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.

18 Feb 2014
21 CFR 110.20(a)(1)

Harborage areas

Cited by Elmina E Akwo, Christopher J Smith, Tara A Gray

18 Feb 2014
21 CFR 110.37(e)(3)

Hand drying

Cited by Elmina E Akwo, Christopher J Smith, Tara A Gray

18 Feb 2014
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Elmina E Akwo, Christopher J Smith, Tara A Gray

18 Feb 2014
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Elmina E Akwo, Christopher J Smith, Tara A Gray

18 Feb 2014
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Elmina E Akwo, Christopher J Smith, Tara A Gray

Inspected site

FPFresh Pasta Delights, Inc.Dallas, United States

Inspection team

CJChristopher J Smith

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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