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Form 483

Ventec Life Systems, Inc. Form 483, 2022-07-27

FDA issued a Form 483 to Ventec Life Systems, Inc. on 2022-07-27 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Ventec Life Systems, Inc. · Bothell, United States · Issued July 27, 2022

Overview

  • 4 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.

27 Jul 2022
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Stephen R Souza

27 Jul 2022
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Stephen R Souza

27 Jul 2022
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Stephen R Souza

27 Jul 2022
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Stephen R Souza

Inspected site

VLVentec Life Systems, Inc.Bothell, United States

Inspection team

SRStephen R Souza

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations4x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF, 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