Exelead, Inc., Indianapolis, IN – FDA Inspections

Inspection records and compliance data for Exelead, Inc. in Indianapolis, Indiana. 12 FDA inspections on record, 2 Form 483s, last inspected September 04, 2025.

Company Profile

This profile covers Exelead, Inc. based in Indianapolis, Indiana, United States.

FDA Inspection History

FDA inspections: 12
OAI: 0
VAI: 10
NAI: 0
Unclassified: 2
Form 483s: 2
Warning letters: 0

First inspected June 17, 2009. Last inspected September 4, 2025.

Most cited issue areas

Procedures for sterile drug products4 inspections
Procedures not in writing, fully followed4 inspections
Control procedures to monitor and validate performance2 inspections

FDA inspections (12)

Date	Result	FDA center(s)	Insp. #
September 4, 2025	Not classified	Human Drugs	1287394
December 20, 2023	VAI	Human Drugs · Drug Quality Assurance	1225603
July 30, 2018	VAI	Human Drugs · Drug Quality Assurance	1062147
May 15, 2018	Not classified	Human Drugs	1055813
April 10, 2015	VAI	Human Drugs · Drug Quality Assurance	922118
May 16, 2014	VAI	Human Drugs · Drug Quality Assurance	878732
November 7, 2013	VAI	Human Drugs · Drug Quality Assurance	854195
April 19, 2013	VAI	Human Drugs · Drug Quality Assurance	832305
May 11, 2012	VAI	Human Drugs · Drug Quality Assurance	783684
June 7, 2011	VAI	Human Drugs · Drug Quality Assurance	729308
June 4, 2010	VAI	Human Drugs · Drug Quality Assurance	666258
June 17, 2009	VAI	Human Drugs · Drug Quality Assurance	594557

FDA documents

Form 483s (1)

Form 483s · December 20, 2023

People (2)

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