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•United States

Frontage Laboratories, Inc., Exton, PA – FDA Inspections

Inspection records and compliance data for Frontage Laboratories, Inc. in Exton, Pennsylvania. 16 FDA inspections on record, 2 Form 483s, last inspected April 14, 2026.

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Company Profile

This profile covers Frontage Laboratories, Inc. based in Exton, Pennsylvania, United States.

FDA Inspection History

FDA inspections
16
OAI
0
VAI
4
NAI
10
Unclassified
2
Form 483s
2
Warning letters
0

First inspected April 7, 2009. Last inspected April 14, 2026.

Most cited issue areas

  • Scientifically sound laboratory controls2 inspections
  • Backup file not maintained1 inspection
  • Data secured in course of each test1 inspection

FDA inspections (16)

DateResultFDA center(s)Insp. #
April 14, 2026VAIHuman Drugs · Drug Quality Assurance1312304
September 5, 2025NAIHuman Drugs · Bioresearch Monitoring1281730
January 10, 2025VAIAnimal Drugs & Feeds · Pre-Approval Evaluation of Animal Drugs and Food Additives1258228
March 31, 2023NAIHuman Drugs · Bioresearch Monitoring1203309
October 15, 2021VAIHuman Drugs · Drug Quality Assurance1155307
November 1, 2019NAIHuman Drugs · Drug Quality Assurance1112214
April 20, 2018NAIHuman Drugs · Bioresearch Monitoring1051857
April 12, 2017Not classifiedHuman Drugs1013161
April 7, 2017Not classifiedHuman Drugs1012975
March 18, 2016VAIHuman Drugs · Drug Quality Assurance965450
March 17, 2016NAIHuman Drugs · Drug Quality Assurance965423
August 30, 2013NAIHuman Drugs · Drug Quality Assurance846768
January 17, 2012NAIHuman Drugs · Drug Quality Assurance763276
April 5, 2011NAIHuman Drugs · Drug Quality Assurance727036
March 19, 2010NAIHuman Drugs · Drug Quality Assurance653017
April 7, 2009NAIHuman Drugs · Drug Quality Assurance578523
FDA documents

Form 483s (4)

  • Form 483s · January 10, 2025
  • Form 483s · February 18, 2022
  • Form 483s · October 15, 2021
  • Form 483s · March 17, 2016

EIRs (2)

  • EIRs · February 18, 2022
  • EIRs · November 1, 2019
People (4)
Anita R. Michael
Person
Michael L. Casner
Person
Tekalign Wondimu
Person
Craig D. Zagata
Person
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Company Information

Name

Frontage Laboratories, Inc.

FEI Number

3006799640

Address

700 Pennsylvania Dr, Exton, Pennsylvania 19341, United States

Country

United States

ID: 1705f97d-14a3-4e46-b8a5-220bf2c4799f

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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