Atlas

Form 483

Light Age, Inc. Form 483, 2017-11-17

FDA issued a Form 483 to Light Age, Inc. on 2017-11-17 with 45 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health45 observations

Light Age, Inc. · Somerset, United States · Issued November 17, 2017

Overview

  • 45 public-safe observations are available for this inspection.
  • 15 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.

17 Nov 2017
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Gobiga Vanniyasingam

17 Nov 2017
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Gobiga Vanniyasingam

17 Nov 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Gobiga Vanniyasingam

17 Nov 2017
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Gobiga Vanniyasingam

17 Nov 2017
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Gobiga Vanniyasingam

Inspected site

LALight Age, Inc.Somerset, United States

Inspection team

GVGobiga Vanniyasingam

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.181Cited across public-safe Form 483 observations3x
21 CFR 820.184Cited across public-safe Form 483 observations3x
21 CFR 820.198(a)Cited across public-safe Form 483 observations3x
21 CFR 820.20(b)Cited across public-safe Form 483 observations3x
21 CFR 820.20(c)Cited across public-safe Form 483 observations3x
21 CFR 820.22Cited across public-safe Form 483 observations3x
21 CFR 820.25(a)Cited across public-safe Form 483 observations3x
21 CFR 820.30(i)Cited across public-safe Form 483 observations3x
21 CFR 820.40(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50(b)Cited across public-safe Form 483 observations3x
21 CFR 820.72(a)Cited across public-safe Form 483 observations3x
21 CFR 820.80(e)Cited across public-safe Form 483 observations3x
21 CFR 820.90(b)(1)Cited across public-safe Form 483 observations3x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 45 observations

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