Form 483

The Danish Pastry House, LLC Form 483, 2014-12-05

FDA issued a Form 483 to The Danish Pastry House, LLC on 2014-12-05 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

The Danish Pastry House, LLC · Watertown, United States · Issued December 5, 2014

Overview

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

5 Dec 2014
21 CFR 110.10(b)(5)

Glove condition

Cited by Thomas Siebertz, Wendy A Johnecheck

5 Dec 2014
21 CFR 110.20(a)(1)

Harborage areas

Cited by Thomas Siebertz, Wendy A Johnecheck

5 Dec 2014
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Thomas Siebertz, Wendy A Johnecheck

5 Dec 2014
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Thomas Siebertz, Wendy A Johnecheck

5 Dec 2014
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Thomas Siebertz, Wendy A Johnecheck

Inspected site

TDThe Danish Pastry House, LLCWatertown, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.40(b)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