Atlas

Form 483

McConnell's Fine Ice Creams, LLC Form 483, 2017-02-10

FDA issued a Form 483 to McConnell's Fine Ice Creams, LLC on 2017-02-10 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

McConnell's Fine Ice Creams, LLC · Oxnard, United States · Issued February 10, 2017

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

10 Feb 2017
21 CFR 110.37(b)(2)

Convey sewage

Cited by Taichun Qin, Greg K Keshishyan

10 Feb 2017
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Taichun Qin, Greg K Keshishyan

10 Feb 2017
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Taichun Qin, Greg K Keshishyan

Inspected site

MFMcConnell's Fine Ice Creams, LLCOxnard, United States

Inspection team

TQTaichun Qin
GKGreg K Keshishyan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.37(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)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 3 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