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Form 483

Apex Medical Technologies, Inc. Form 483, 2026-01-15

FDA issued a Form 483 to Apex Medical Technologies, Inc. on 2026-01-15 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Apex Medical Technologies, Inc. · San Diego, United States · Issued January 15, 2026

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.

15 Jan 2026
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jae H Lee

15 Jan 2026
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jae H Lee

15 Jan 2026
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Jae H Lee

15 Jan 2026
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Jae H Lee

Inspected site

AMApex Medical Technologies, Inc.San Diego, United States

Inspection team

JHJae H Lee

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)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