Atlas

FDA-Inspected Site

Exelead, Inc.

18 FDA inspections are on record for Exelead, Inc. in Indianapolis, United States.

Clean· No action indicated

Indianapolis, United States · Last updated July 10, 2026

Overview

  • 18 FDA inspections are on record.
  • 12 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-04.

At a glance

Inspections

18

Form 483s

12

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Aug 2025 – 4 Sep 2025Human DrugsClean
11 Dec 2023 – 20 Dec 2023Human Drugs483On file
9 Jul 2018 – 30 Jul 2018Human DrugsClean
7 May 2018 – 15 May 2018Human Drugs483On file
23 Mar 2015 – 10 Apr 2015Human Drugs483View 483 →
12 May 2014 – 16 May 2014Human Drugs483View 483 →
6 Nov 2013 – 7 Nov 2013Human Drugs483View 483 →
15 Apr 2013 – 19 Apr 2013Human Drugs483On file
24 May 2012Not recorded483On file
11 May 2012Not recorded483View 483 →
7 Jun 2011Not recorded483View 483 →
4 Jun 2010Not recorded483View 483 →

Observations on record

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

10 Apr 2015
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Jeffrey D Meng, Geneve M Parks, Michael G Truchan, Geneve M Maxwell

10 Apr 2015
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Jeffrey D Meng, Geneve M Parks, Michael G Truchan, Geneve M Maxwell

10 Apr 2015
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jeffrey D Meng, Geneve M Parks, Michael G Truchan, Geneve M Maxwell

10 Apr 2015
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Jeffrey D Meng, Geneve M Parks, Michael G Truchan, Geneve M Maxwell

10 Apr 2015
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Jeffrey D Meng, Geneve M Parks, Michael G Truchan, Geneve M Maxwell

Investigators

FDA investigators tied to this site in the record.

Robert M Barbosa6 insp.
Meisha R Sampson3 insp.
Rebecca E Dombrowski3 insp.
Lakshmi Ran Narasimhan2 insp.
Larry K Austin2 insp.
Robert J Ham1 insp.
Gabriel Bermudez-Picart1 insp.
Lisa L Flores1 insp.
Muna Algharibeh1 insp.
Jazmine N Still1 insp.
Bo Chi1 insp.
Jeffrey D Meng1 insp.
Geneve M Parks1 insp.
Michael G Truchan1 insp.
Geneve M Maxwell1 insp.
Meisha R Waters1 insp.
Colleen Thomas1 insp.
Michele L Forster1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations4x
21 CFR 211.22(d)Cited across public-safe Form 483 observations4x
21 CFR 211.192Cited across public-safe Form 483 observations3x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.67(b)Cited across public-safe Form 483 observations2x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.125(e)Cited across public-safe Form 483 observations1x
21 CFR 211.130Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.167(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Exelead, Inc.'s 12 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