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Form 483

R&D Engineering, Inc. of Earlham Form 483, 2025-04-23

FDA issued a Form 483 to R&D Engineering, Inc. of Earlham on 2025-04-23 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

R&D Engineering, Inc. of Earlham · Earlham, United States · Issued April 23, 2025

Overview

  • 2 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.

23 Apr 2025
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Clifford F Long

23 Apr 2025
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Clifford F Long

Inspected site

RER&D Engineering, Inc. of EarlhamEarlham, United States

Inspection team

CFClifford F Long

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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