Form 483

Benjamin's Bakery, Inc. Form 483, 2017-12-19

FDA issued a Form 483 to Benjamin's Bakery, Inc. on 2017-12-19 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

Benjamin's Bakery, Inc. · Surfside Beach, United States · Issued December 19, 2017

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

19 Dec 2017
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Myckie M Jacobsen

19 Dec 2017
21 CFR 110.10(b)(6)

Failure to wear

Cited by Myckie M Jacobsen

19 Dec 2017
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Myckie M Jacobsen

19 Dec 2017
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Myckie M Jacobsen

19 Dec 2017
21 CFR 110.20(b)(7)

Screening

Cited by Myckie M Jacobsen

Inspected site

BBBenjamin's Bakery, Inc.Surfside Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)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(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)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