Form 483

Fran's Chocolates Ltd Form 483, 2009-04-24

FDA issued a Form 483 to Fran's Chocolates Ltd on 2009-04-24 with 3 public-safe observations.

483· Form 483 issued3 observations

Fran's Chocolates Ltd · Seattle, United States · Issued April 24, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

24 Apr 2009
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Jinkee M Vila Binayug, Anita Narula

24 Apr 2009
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Jinkee M Vila Binayug, Anita Narula

24 Apr 2009
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Jinkee M Vila Binayug, Anita Narula

Inspected site

FCFran's Chocolates LtdSeattle, United States

Inspection team

JMJinkee M Vila Binayug

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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