Atlas

FDA-Inspected Site

Kedrion Biopharma Inc.

13 FDA inspections are on record for Kedrion Biopharma Inc. in Melville, United States.

483· Form 483 issued

Melville, United States · Last updated August 15, 2026

Overview

  • 13 FDA inspections are on record.
  • 11 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-21.

At a glance

Inspections

13

Form 483s

11

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 May 2026 – 21 May 2026Biologics483View 483 →
20 Mar 2024 – 27 Mar 2024Biologics483On file
14 Jun 2021 – 25 Jun 2021Biologics483On file
2 Dec 2019 – 6 Dec 2019Biologics483On file
13 Nov 2018 – 16 Nov 2018Biologics483On file
14 Aug 2018 – 29 Aug 2018Biologics483On file
21 Apr 2016 – 5 May 2016Biologics483On file
23 Sep 2014 – 29 Sep 2014Biologics483On file
2 Aug 2012Not recorded483On file
11 Mar 2010Not recorded483On file
21 Jul 2009Not recorded483On file
20 Apr 2005Not recordedClean

Observations on record

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

21 May 2026
21 CFR 211.105(a)

Identification of containers, lines, equipment

Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton

21 May 2026
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton

21 May 2026
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton

21 May 2026
21 CFR 211.184(c)

Individual inventory record

Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton

21 May 2026
21 CFR 211.188(b)

Batch production and Batch Control Record Requirements

Cited by Scott T Ballard, Lu Deng, Malgorzata G Norton

Investigators

FDA investigators tied to this site in the record.

Malgorzata G Norton3 insp.
Burnell M Henry3 insp.
Lu Deng2 insp.
Susan M Jackson2 insp.
Jacqueline M Diaz Albert2 insp.
Scott T Ballard1 insp.
Travis S Bradley1 insp.
Ann M Stewart1 insp.
Linda Thai1 insp.
Pankaj H Amin1 insp.
Holly Brevig1 insp.
Timothy M Martin1 insp.
Irina Gaberman1 insp.
Bradley J Dworak1 insp.
Joan Johnson1 insp.
Olga Simakova1 insp.
Vioela J Caze1 insp.
Christian Lynch1 insp.
Deborah M Trout1 insp.
Sarah B Tanksley1 insp.
Prabhu P Raju1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.184(c)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 601.12(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Kedrion Biopharma Inc.'s 11 Form 483s

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