Form 483

Bread & Chocolate, Inc Form 483, 2011-06-16

FDA issued a Form 483 to Bread & Chocolate, Inc on 2011-06-16 with 6 public-safe observations.

483· Form 483 issued6 observations

Bread & Chocolate, Inc · Alexandria, United States · Issued June 16, 2011

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

16 Jun 2011
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Rina Bhikha

16 Jun 2011
21 CFR 110.20(b)(1)

Sufficient space

Cited by Rina Bhikha

16 Jun 2011
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Rina Bhikha

16 Jun 2011
21 CFR 110.35(d)

Failure to clean - general

Cited by Rina Bhikha

16 Jun 2011
21 CFR 110.35(d)(5)

Safe and adequate for use

Cited by Rina Bhikha

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 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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