Atlas

Form 483

Pac-dent, Inc. Form 483, 2026-03-12

FDA issued a Form 483 to Pac-dent, Inc. on 2026-03-12 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Pac-dent, Inc. · Brea, United States · Issued March 12, 2026

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.

12 Mar 2026
21 CFR 830.310(b)

GUDID Information required for unique device identification.

Cited by Marlo-Ian M Alintanahin

12 Mar 2026
ISO 13485:2016 Clause 7.4.1

Records of supplier (re)evaluation, selection, and monitoring not maintained

Cited by Marlo-Ian M Alintanahin

Inspected site

PIPac-dent, Inc.Brea, United States

Inspection team

MMMarlo-Ian M Alintanahin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 830.310(b)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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