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Form 483

Cincinnati Sub-Zero Products LLC Form 483, 2011-11-18

FDA issued a Form 483 to Cincinnati Sub-Zero Products LLC on 2011-11-18 with 1 public-safe observation.

483· Form 483 issued1 observation

Cincinnati Sub-Zero Products LLC · Blue Ash, United States · Issued November 18, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

18 Nov 2011
21 CFR 820.198(c)

Investigation of device failures

Cited by Laureen M Geniusz, Maribeth G Grattan

Inspected site

CSCincinnati Sub-Zero Products LLCBlue Ash, United States

Inspection team

LMLaureen M Geniusz
MGMaribeth G Grattan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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  • 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