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•United States

Adare Pharmaceuticals, Inc., Vandalia, OH – FDA Inspections

Inspection records and compliance data for Adare Pharmaceuticals, Inc. in Vandalia, Ohio. 9 FDA inspections on record, 1 Form 483, last inspected February 25, 2025.

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Company Profile

This profile covers Adare Pharmaceuticals, Inc. based in Vandalia, Ohio, United States.

FDA Inspection History

FDA inspections
9
OAI
0
VAI
3
NAI
6
Form 483s
1
Warning letters
0

First inspected November 20, 2009. Last inspected February 25, 2025.

Most cited issue areas

  • Investigations of discrepancies, failures1 inspection

FDA inspections (9)

DateResultFDA center(s)Insp. #
February 25, 2025VAIHuman Drugs · Drug Quality Assurance1261982
January 25, 2019NAIHuman Drugs · Drug Quality Assurance1077858
July 11, 2018NAIHuman Drugs · Bioresearch Monitoring1063146
May 19, 2017NAIHuman Drugs · Drug Quality Assurance1014959
November 14, 2014VAIMedical Devices & Rad Health · Compliance: Devices904602
November 16, 2012NAIHuman Drugs · Drug Quality Assurance809244
December 21, 2011VAIHuman Drugs · Drug Quality Assurance767444
June 17, 2011NAIHuman Drugs · Drug Quality Assurance736349
November 20, 2009NAIHuman Drugs · Drug Quality Assurance629916
FDA documents

Form 483s (1)

  • Form 483s · February 25, 2025

EIRs (4)

  • EIRs · February 25, 2025
  • EIRs · January 25, 2019
  • EIRs · July 11, 2018
  • EIRs · May 19, 2017
People (5)
Juan Pablo Gutierrez
Person
Andrea Engle
Person
Douglas E. Wallace
Person
Michael T. Perrin
Person
Lauren N. Smith
Person
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Company Information

Name

Adare Pharmaceuticals, Inc.

FEI Number

1525864

Address

845 Center Dr, Vandalia, Ohio 45377, United States

Country

United States

ID: b1aa5308-ecbd-4a48-adf0-0ed6bd2470c5

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Contact
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🇪🇺+48 532-447-507
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