Atlas

Form 483

Benjamin D. Elder, MD, PhD Form 483, 2026-03-27

FDA issued a Form 483 to Benjamin D. Elder, MD, PhD on 2026-03-27 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Benjamin D. Elder, MD, PhD · Rochester, United States · Issued March 27, 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.

27 Mar 2026
21 CFR 812.100

Investigator non-compliance with agreement/plan/regulations

Cited by Stephen O Agyemang

27 Mar 2026
21 CFR 812.140(a)(2)(i)

Investigator device accountability inadequate

Cited by Stephen O Agyemang

Inspected site

BDBenjamin D. Elder, MD, PhDRochester, United States

Inspection team

SOStephen O Agyemang

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 812.100Cited across public-safe Form 483 observations1x
21 CFR 812.140(a)(2)(i)Cited 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