Atlas

FDA-Inspected Site

Sun Dental Laboratories, LLC

2 FDA inspections are on record for Sun Dental Laboratories, LLC in Saint Petersburg, United States.

483· Form 483 issued

Saint Petersburg, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-01.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 1 Apr 2026Medical Devices & Rad Health483View 483 →
19 Sep 2023 – 20 Sep 2023Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

1 Apr 2026
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Marvin A Marenco, Pascal G Felix

1 Apr 2026
21 CFR 820.35(c)

UDI was not recorded for each medical device or batch

Cited by Marvin A Marenco, Pascal G Felix

1 Apr 2026
ISO 13485:2016 Clause 4.1.3

QMS processes not adequate

Cited by Marvin A Marenco, Pascal G Felix

1 Apr 2026
ISO 13485:2016 Clause 5.1

Lack of evidence for top management's commitment to QMS

Cited by Marvin A Marenco, Pascal G Felix

1 Apr 2026
ISO 13485:2016 Clause 7.1

Required elements not determined in planning product realization

Cited by Marvin A Marenco, Pascal G Felix

Investigators

FDA investigators tied to this site in the record.

Marvin A Marenco1 insp.
Pascal G Felix1 insp.
Suzanne M Healy1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.120(b)Cited across public-safe Form 483 observations1x
21 CFR 820.35(c)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.3Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 5.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.3Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sun Dental Laboratories, LLC's 2 Form 483s

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat