Atlas

Form 483

Access Point Technologies EP, Inc. Form 483, 2026-05-01

FDA issued a Form 483 to Access Point Technologies EP, Inc. on 2026-05-01 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Access Point Technologies EP, Inc. · Rogers, United States · Issued May 1, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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 May 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Albert L Nguyen

1 May 2026
ISO 13485:2016 Clause 6.4.1

Work environment requirements and procedures not documented

Cited by Albert L Nguyen

1 May 2026
ISO 13485:2016 Clause 7.5.7

Sterilization and sterile barrier system validation procedures not documented

Cited by Albert L Nguyen

1 May 2026
ISO 13485:2016 Clause 8.5.2

Corrective action procedures not documented

Cited by Albert L Nguyen

Inspected site

APAccess Point Technologies EP, Inc.Rogers, United States

Inspection team

ALAlbert L Nguyen

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.7Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, 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