Form 483

BAKERY MANAGEMENT CORPORATION Form 483, 2009-11-06

FDA issued a Form 483 to BAKERY MANAGEMENT CORPORATION on 2009-11-06 with 14 public-safe observations.

483· Form 483 issued14 observations

BAKERY MANAGEMENT CORPORATION · Miami, United States · Issued November 6, 2009

Overview

  • 14 public-safe observations are available for this inspection.
  • 14 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.

6 Nov 2009
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Joanne E King, Earl Echon

6 Nov 2009
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Joanne E King, Earl Echon

6 Nov 2009
21 CFR 110.20(b)(1)

Sufficient space

Cited by Joanne E King, Earl Echon

6 Nov 2009
21 CFR 110.20(b)(4)

Spacing of equipment

Cited by Joanne E King, Earl Echon

6 Nov 2009
21 CFR 110.20(b)(7)

Screening

Cited by Joanne E King, Earl Echon

Inspected site

BMBAKERY MANAGEMENT CORPORATIONMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)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 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(c)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
21 CFR 123.11(a)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 14 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