Atlas

FDA-Inspected Site

Mark S. Denker, MD PA

7 FDA inspections are on record for Mark S. Denker, MD PA in Boca Raton, United States.

Clean· No action indicated

Boca Raton, United States · Last updated August 15, 2026

Overview

  • 7 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-07-14.

At a glance

Inspections

7

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Jul 2026BiologicsClean
5 Jun 2023 – 6 Jun 2023BiologicsClean
31 May 2022 – 6 Jun 2022Biologics483View 483 →
10 May 2018 – 24 May 2018Biologics483View 483 →
18 Nov 2015Biologics483View 483 →
5 Dec 2011Not recordedClean
23 Jul 2009Not recordedClean

Observations on record

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

6 Jun 2022
21 CFR 1271.47(a)

Testing, screening, donor eligibility procedures

Cited by Ivan E Reyes, Samantha J Pinizzotto

6 Jun 2022
21 CFR 1271.50(b)(1)

Donor screening standards

Cited by Ivan E Reyes, Samantha J Pinizzotto

6 Jun 2022
21 CFR 1271.55(b)(2)

Listing and interpretation of CD tests performed

Cited by Ivan E Reyes, Samantha J Pinizzotto

6 Jun 2022
21 CFR 1271.55(b)(4)

Reasons for ineligibility on summary

Cited by Ivan E Reyes, Samantha J Pinizzotto

6 Jun 2022
21 CFR 1271.55(d)(1)(iii)

Documentation--determination, by whom, date

Cited by Ivan E Reyes, Samantha J Pinizzotto

Investigators

FDA investigators tied to this site in the record.

Ivan E Reyes3 insp.
Samantha J Pinizzotto1 insp.
Colleen M Aspinwall1 insp.
Barbara T Carmichael1 insp.
Ethan P Stegman1 insp.
Jana L Caylor1 insp.
Ronnie E Jackson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 1271.50(b)(1)Cited across public-safe Form 483 observations4x
21 CFR 1271.47(a)Cited across public-safe Form 483 observations3x
21 CFR 1271.55(b)(4)Cited across public-safe Form 483 observations3x
21 CFR 1271.75(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 1271.55(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 1271.55(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 1271.65(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 1271.75(d)Cited across public-safe Form 483 observations2x
21 CFR 1271.50(a)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.55(d)(1)(iii)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Mark S. Denker, MD PA's 3 Form 483s

Source PDFs, verbatim observations, 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