Form 483

PROTANO'S BAKERY, LLC Form 483, 2010-01-15

FDA issued a Form 483 to PROTANO'S BAKERY, LLC on 2010-01-15 with 17 public-safe observations.

483· Form 483 issued17 observations

PROTANO'S BAKERY, LLC · Hollywood, United States · Issued January 15, 2010

Overview

  • 17 public-safe observations are available for this inspection.
  • 15 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.

15 Jan 2010
21 CFR 110.10(b)(4)

Hand jewelry - remove/cover

Cited by Marc Balzarini

15 Jan 2010
21 CFR 110.10(b)(6)

Failure to wear

Cited by Marc Balzarini

15 Jan 2010
21 CFR 110.10(b)(7)

Storage of personal items

Cited by Marc Balzarini

15 Jan 2010
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Marc Balzarini

15 Jan 2010
21 CFR 110.20(a)(1)

Harborage areas

Cited by Marc Balzarini

Inspected site

PBPROTANO'S BAKERY, LLCHollywood, 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 110.35(a)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(4)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)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(1)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 110.37(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)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 17 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