FDA-Inspected Site

Biorez, Inc

2 FDA inspections are on record for Biorez, Inc in New Haven, United States.

Clean· No action indicated

New Haven, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-05-13.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 May 2026 – 13 May 2026Medical Devices & Rad HealthClean
1 Aug 2023 – 4 Aug 2023Medical Devices & Rad Health483View 483 →

Observations on record

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

4 Aug 2023
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Jeffrey J Thibodeau

4 Aug 2023
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Jeffrey J Thibodeau

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.50Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Biorez, Inc's 1 Form 483

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