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Form 483

Kleen Test Products Corporation Form 483, 2022-03-25

FDA issued a Form 483 to Kleen Test Products Corporation on 2022-03-25 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Kleen Test Products Corporation · Port Washington, United States · Issued March 25, 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.

25 Mar 2022
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nicholas T Domer

25 Mar 2022
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nicholas T Domer

25 Mar 2022
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nicholas T Domer

25 Mar 2022
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Nicholas T Domer

Inspected site

KTKleen Test Products CorporationPort Washington, United States

Inspection team

NTNicholas T Domer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.75(a)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