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Form 483

Focalyx Technologies, LLC. Form 483, 2025-12-01

FDA issued a Form 483 to Focalyx Technologies, LLC. on 2025-12-01 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Focalyx Technologies, LLC. · Hialeah, United States · Issued December 1, 2025

Overview

  • 2 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.

1 Dec 2025
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Marvin A Marenco

1 Dec 2025
21 CFR 820.30(g)

Design validation - user needs and intended uses

Cited by Marvin A Marenco

Inspected site

FTFocalyx Technologies, LLC.Hialeah, United States

Inspection team

MAMarvin A Marenco

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

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  • 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