Form 483

Life Sensing Instruments, Inc. Form 483, 2019-08-14

FDA issued a Form 483 to Life Sensing Instruments, Inc. on 2019-08-14 with 24 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health24 observations

Life Sensing Instruments, Inc. · Charlotte, United States · Issued August 14, 2019

Overview

  • 24 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.

14 Aug 2019
21 CFR 820.120(b)

Labeling inspection - UDI

Cited by Gamal A Norton

14 Aug 2019
21 CFR 820.120(b)

Labeling inspection - UDI

Cited by Gamal A Norton

14 Aug 2019
21 CFR 820.184

DHR content

Cited by Gamal A Norton

14 Aug 2019
21 CFR 820.184

DHR content

Cited by Gamal A Norton

14 Aug 2019
21 CFR 820.30(f)

Design verification - documentation

Cited by Gamal A Norton

Inspected site

LSLife Sensing Instruments, Inc.Charlotte, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations8x
21 CFR 820.184Cited across public-safe Form 483 observations4x
21 CFR 820.30(f)Cited across public-safe Form 483 observations4x
21 CFR 820.75(a)Cited across public-safe Form 483 observations4x
21 CFR 820.120(b)Cited across public-safe Form 483 observations2x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 24 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