FDA-Inspected Site

KBI Biopharma, Inc.

8 FDA inspections are on record for KBI Biopharma, Inc. in Durham, United States.

483· Form 483 issued

Durham, United States · Last updated July 10, 2026

Overview

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

At a glance

Inspections

8

Form 483s

3

EIRs

5

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Mar 2026 – 1 Apr 2026Human Drugs483On file
11 Jun 2024 – 18 Jun 2024Human Drugs483On file
10 Jan 2022 – 13 Jan 2022Human DrugsClean
23 Sep 2020 – 29 Sep 2020Human Drugs483On file
9 Apr 2018 – 11 Apr 2018Human DrugsClean
14 Jul 2015 – 16 Jul 2015Human DrugsClean
29 Aug 2012Not recordedClean
9 Oct 2009Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Viviana Matta2 insp.
Michael Shanks1 insp.
Olumide A Martins1 insp.
Ayyappan Rathakrishnan1 insp.
Kamal N Tiwari1 insp.
Adam R Cooke1 insp.
Lillie D Witcher1 insp.
Lauryl A Smith1 insp.
Daveta L Bailey1 insp.
Lesley K Satterwhite1 insp.
Ibad U Khan1 insp.
Jose M Gonzalez1 insp.

Full site report

Get the verbatim findings behind KBI Biopharma, Inc.'s 3 Form 483s

The full inspection record, as Atlas holds it, 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

Related sites