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Form 483

LumiQuick Diagnostics Inc. Form 483, 2015-07-24

FDA issued a Form 483 to LumiQuick Diagnostics Inc. on 2015-07-24 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

LumiQuick Diagnostics Inc. · Santa Clara, United States · Issued July 24, 2015

Overview

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

Inspectional observations

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

24 Jul 2015
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Adam S Freeman

24 Jul 2015
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Adam S Freeman

Inspected site

LDLumiQuick Diagnostics Inc.Santa Clara, United States

Inspection team

ASAdam S Freeman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x

Full 483 report

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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