Form 483

Rolf's Patisserie, Inc. Form 483, 2011-12-09

FDA issued a Form 483 to Rolf's Patisserie, Inc. on 2011-12-09 with 15 public-safe observations.

483· Form 483 issued15 observations

Rolf's Patisserie, Inc. · Lincolnwood, United States · Issued December 9, 2011

Overview

15 public-safe observations are available for this inspection.
15 structured CFR citations are represented.
8 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

9 Dec 2011

21 CFR 110.10(b)(2)

Personal cleanliness

Cited by Patrick E Gainer, Kathleen S Tormey, Margaret Torres-Vazquez, Brittany R Laymon, Ashley L Reiber, Jennifer C Johnson, Jeanne J Chiu, Tara C Alcazar

9 Dec 2011

21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Patrick E Gainer, Kathleen S Tormey, Margaret Torres-Vazquez, Brittany R Laymon, Ashley L Reiber, Jennifer C Johnson, Jeanne J Chiu, Tara C Alcazar

9 Dec 2011

21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Patrick E Gainer, Kathleen S Tormey, Margaret Torres-Vazquez, Brittany R Laymon, Ashley L Reiber, Jennifer C Johnson, Jeanne J Chiu, Tara C Alcazar

9 Dec 2011

21 CFR 110.20(b)(4)

Drip and condensate

Cited by Patrick E Gainer, Kathleen S Tormey, Margaret Torres-Vazquez, Brittany R Laymon, Ashley L Reiber, Jennifer C Johnson, Jeanne J Chiu, Tara C Alcazar

9 Dec 2011

21 CFR 110.35(b)(2)

Storage requirements

Cited by Patrick E Gainer, Kathleen S Tormey, Margaret Torres-Vazquez, Brittany R Laymon, Ashley L Reiber, Jennifer C Johnson, Jeanne J Chiu, Tara C Alcazar

Inspected site

RPRolf's Patisserie, Inc.Lincolnwood, United States

Inspection team

PEPatrick E Gainer

KSKathleen S Tormey

MTMargaret Torres-Vazquez

BRBrittany R Laymon

ALAshley L Reiber

JCJennifer C Johnson

JJJeanne J Chiu

TCTara C Alcazar

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 110.10(b)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 110.10(b)(3)	Cited across public-safe Form 483 observations	1x
21 CFR 110.10(c)	Cited across public-safe Form 483 observations	1x
21 CFR 110.20(b)(4)	Cited across public-safe Form 483 observations	1x
21 CFR 110.35(b)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 110.35(c)	Cited across public-safe Form 483 observations	1x
21 CFR 110.35(d)	Cited across public-safe Form 483 observations	1x
21 CFR 110.37(b)(3)	Cited across public-safe Form 483 observations	1x
21 CFR 110.37(e)	Cited across public-safe Form 483 observations	1x
21 CFR 110.40(a)	Cited across public-safe Form 483 observations	1x
21 CFR 110.40(c)	Cited across public-safe Form 483 observations	1x
21 CFR 110.80	Cited across public-safe Form 483 observations	1x
21 CFR 110.80(b)(13)	Cited across public-safe Form 483 observations	1x
21 CFR 110.80(b)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 110.80(b)(3)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 15 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