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Form 483

E-Beam Services, Inc. Form 483, 2023-04-27

FDA issued a Form 483 to E-Beam Services, Inc. on 2023-04-27 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

E-Beam Services, Inc. · Cranbury, United States · Issued April 27, 2023

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 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.

27 Apr 2023
21 CFR 820.184

DHR content

Cited by Kwong P Lee

27 Apr 2023
21 CFR 820.184

DHR content

Cited by Kwong P Lee

27 Apr 2023
21 CFR 820.40(b)

Change records, content

Cited by Kwong P Lee

27 Apr 2023
21 CFR 820.40(b)

Change records, content

Cited by Kwong P Lee

Inspected site

ESE-Beam Services, Inc.Cranbury, United States

Inspection team

KPKwong P Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.40(b)Cited across public-safe Form 483 observations2x

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