Form 483

The Danish Pastry House, LLC Form 483, 2009-05-22

FDA issued a Form 483 to The Danish Pastry House, LLC on 2009-05-22 with 10 public-safe observations.

483· Form 483 issued10 observations

The Danish Pastry House, LLC · Watertown, United States · Issued May 22, 2009

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

22 May 2009
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Margaret E Walsh, Ramon E Martinez

22 May 2009
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Margaret E Walsh, Ramon E Martinez

22 May 2009
21 CFR 110.20(a)(1)

Harborage areas

Cited by Margaret E Walsh, Ramon E Martinez

22 May 2009
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Margaret E Walsh, Ramon E Martinez

22 May 2009
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Margaret E Walsh, Ramon E Martinez

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)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)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 110.20(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)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 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)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