Form 483

Middle East Bakery, Inc. Form 483, 2008-10-28

FDA issued a Form 483 to Middle East Bakery, Inc. on 2008-10-28 with 14 public-safe observations.

483· Form 483 issued14 observations

Middle East Bakery, Inc. · Lawrence, United States · Issued October 28, 2008

Overview

  • 14 public-safe observations are available for this inspection.
  • 13 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.

28 Oct 2008
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Christopher M Elliott

28 Oct 2008
21 CFR 110.10(d)

Supervision

Cited by Christopher M Elliott

28 Oct 2008
21 CFR 110.20(b)(2)

Contamination with microorganisms, chemicals, filth, etc.

Cited by Christopher M Elliott

28 Oct 2008
21 CFR 110.20(b)(6)

Adequate ventilation

Cited by Christopher M Elliott

28 Oct 2008
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Christopher M Elliott

Inspected site

MEMiddle East Bakery, Inc.Lawrence, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.10(d)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.40(b)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(6)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