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•United States

Catalent Maryland Inc, Harmans, MD – FDA Inspections

Inspection records and compliance data for Catalent Maryland Inc in Harmans, Maryland. 5 FDA inspections on record, 2 Form 483s, last inspected April 28, 2025.

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Company Profile

This profile covers Catalent Maryland Inc based in Harmans, Maryland, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
2
NAI
1
Unclassified
2
Form 483s
2
Warning letters
0

First inspected November 17, 2021. Last inspected April 28, 2025.

FDA inspections (5)

DateResultFDA center(s)Insp. #
April 28, 2025Not classifiedBiologics1276283
November 15, 2024Not classifiedBiologics1252977
March 10, 2023VAIBiologics · Vaccines and Allergenic Products1207147
January 24, 2023NAIBiologics · Human Cellular, Tissue, and Gene Therapies1197573
November 17, 2021VAIBiologics · Human Cellular, Tissue, and Gene Therapies1156961
FDA documents

Form 483s (4)

  • Form 483s · April 28, 2025
  • Form 483s · March 10, 2023
  • Form 483s · November 17, 2021
  • Form 483s

EIRs (2)

  • EIRs · March 10, 2023
  • EIRs · November 17, 2021
People (6)
Wei Bo Liang, Ph.D., Visiting Associate
Person
Andrew Byrnes
Person
Claire M. Minden
Person
Debra M. Emerson
Person
Gowri Manickam
Person
Chad Atwell
Person
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AGC Biologics, Inc.
Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC
GenTrac, Inc.
Company Information

Name

Catalent Maryland Inc

FEI Number

3015434301

Address

7555 Harmans Rd, Harmans, Maryland 21077, United States

Country

United States

ID: fbdaa987-e6a7-466f-b42b-1f23193725d8

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