Form 483

Bread & Chocolate, Inc Form 483, 2016-10-11

FDA issued a Form 483 to Bread & Chocolate, Inc on 2016-10-11 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Bread & Chocolate, Inc · Alexandria, United States · Issued October 11, 2016

Overview

  • 12 public-safe observations are available for this inspection.
  • 6 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

11 Oct 2016
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Mohamad A Chahine, Karen A Spencer, Shelby W Brown

11 Oct 2016
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Mohamad A Chahine, Karen A Spencer, Shelby W Brown

11 Oct 2016
21 CFR 110.10(b)(5)

Glove condition

Cited by Mohamad A Chahine, Karen A Spencer, Shelby W Brown

11 Oct 2016
21 CFR 110.10(b)(5)

Glove condition

Cited by Mohamad A Chahine, Karen A Spencer, Shelby W Brown

11 Oct 2016
21 CFR 110.10(b)(6)

Failure to wear

Cited by Mohamad A Chahine, Karen A Spencer, Shelby W Brown

Inspected site

B&Bread & Chocolate, IncAlexandria, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations2x
21 CFR 110.35(d)Cited across public-safe Form 483 observations2x
21 CFR 110.40(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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