Atlas

Form 483

The Danish Pastry House, LLC Form 483, 2022-07-13

FDA issued a Form 483 to The Danish Pastry House, LLC on 2022-07-13 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

The Danish Pastry House, LLC · Watertown, United States · Issued July 13, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

13 Jul 2022
21 CFR 117.10

Personnel

Cited by John P Shelton

13 Jul 2022
21 CFR 117.20(a)

Grounds

Cited by John P Shelton

13 Jul 2022
21 CFR 117.80(c)

Manufacturing, processing, packing, holding - Controls

Cited by John P Shelton

Inspected site

TDThe Danish Pastry House, LLCWatertown, United States

Inspection team

JPJohn P Shelton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.20(a)Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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