Form 483

Mellos Partners LLC Form 483, 2010-06-07

FDA issued a Form 483 to Mellos Partners LLC on 2010-06-07 with 6 public-safe observations.

483· Form 483 issued6 observations

Mellos Partners LLC · Chicago, United States · Issued June 7, 2010

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

7 Jun 2010
21 CFR 110.20(b)(7)

Screening

Cited by Nicole S Williams

7 Jun 2010
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Nicole S Williams

7 Jun 2010
21 CFR 110.35(b)(2)

Storage requirements

Cited by Nicole S Williams

7 Jun 2010
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Nicole S Williams

7 Jun 2010
21 CFR 110.80(a)(1)

Storage

Cited by Nicole S Williams

Inspected site

MPMellos Partners LLCChicago, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
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 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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