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Form 483

Sage Products, LLC Form 483, 2014-01-15

FDA issued a Form 483 to Sage Products, LLC on 2014-01-15 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Sage Products, LLC · Cary, United States · Issued January 15, 2014

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.

15 Jan 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Christina A Miller, John M Seale

Inspected site

SPSage Products, LLCCary, United States

Inspection team

CAChristina A Miller
JMJohn M Seale

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited 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 source PDF and 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