Form 483

Dragonfly Cakes, LLC Form 483, 2012-08-08

FDA issued a Form 483 to Dragonfly Cakes, LLC on 2012-08-08 with 7 public-safe observations.

483· Form 483 issued7 observations

Dragonfly Cakes, LLC · Sausalito, United States · Issued August 8, 2012

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.

8 Aug 2012
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Damon A Growl, Terrence Gee

8 Aug 2012
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Damon A Growl, Terrence Gee

8 Aug 2012
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Damon A Growl, Terrence Gee

8 Aug 2012
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Damon A Growl, Terrence Gee

8 Aug 2012
21 CFR 110.35(b)(2)

Storage requirements

Cited by Damon A Growl, Terrence Gee

Inspected site

DCDragonfly Cakes, LLCSausalito, 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)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)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