Form 483

Brooklyn Bakery Inc Form 483, 2016-12-16

FDA issued a Form 483 to Brooklyn Bakery Inc on 2016-12-16 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Brooklyn Bakery Inc · Brooklyn, United States · Issued December 16, 2016

Overview

  • 10 public-safe observations are available for this inspection.
  • 8 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 Dec 2016
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Wayne J Meyer

16 Dec 2016
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Wayne J Meyer

16 Dec 2016
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Wayne J Meyer

16 Dec 2016
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Wayne J Meyer

16 Dec 2016
21 CFR 110.20(b)(4)

Drip and condensate

Cited by Wayne J Meyer

Inspected site

BBBrooklyn Bakery IncBrooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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