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•United States

Catalent Pharma Solutions LLC, Morrisville, NC – FDA Inspections

Inspection records and compliance data for Catalent Pharma Solutions LLC in Morrisville, North Carolina. 13 FDA inspections on record (2 OAI), 3 Form 483s, last inspected May 22, 2026.

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Company Profile

This profile covers Catalent Pharma Solutions LLC based in Morrisville, North Carolina, United States.

FDA Inspection History

FDA inspections
13
OAI
2
VAI
4
NAI
5
Unclassified
2
Form 483s
3
Warning letters
0

First inspected November 18, 2009. Last inspected May 22, 2026.

Most cited issue areas

  • Calibration/Inspection/Checking not done1 inspection
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Design input - Lack of or inadequate procedures1 inspection

FDA inspections (13)

DateResultFDA center(s)Insp. #
May 22, 2026Not classifiedHuman Drugs · Drug Quality Assurance1303072
May 24, 2024VAIBiologics · Blood and Blood Products1229061
December 15, 2022VAIHuman Drugs · Drug Quality Assurance1195585
September 28, 2020OAIHuman Drugs · Drug Quality Assurance1131607
December 20, 2019NAIHuman Drugs · Drug Quality Assurance1116748
August 2, 2019Not classifiedHuman Drugs1102199
March 4, 2019OAIAnimal Drugs & Feeds, Human Drugs · Generic Drug Evaluation1081169
February 1, 2019NAIHuman Drugs · Bioresearch Monitoring1086471
May 19, 2017VAIHuman Drugs · Drug Quality Assurance1014725
March 20, 2015VAIHuman Drugs · Drug Quality Assurance919124
February 14, 2013NAIHuman Drugs · Drug Quality Assurance818956
November 11, 2010NAIHuman Drugs · Drug Quality Assurance699296
November 18, 2009NAIHuman Drugs · Drug Quality Assurance634689
FDA documents

Form 483s (6)

  • Form 483s · May 22, 2026
  • Form 483s · May 24, 2024
  • Form 483s · December 15, 2022
  • Form 483s · September 28, 2020
  • Form 483s · March 4, 2019
  • Form 483s · May 19, 2017

EIRs (2)

  • EIRs · December 20, 2019
  • EIRs · May 19, 2017
Other regulators (1)
  • UK MHRA · 1 inspection · last September 27, 2017
People (5)
Jared P. Stevens
Person
Tajah L. Blackburn
Person
Denis A. Narlock II
Person
Vicki L. Schuler
Person
Adam R. Cooke
Person
Related Companies (10)

Companies with similar regulatory profiles, compliance history, and operations.

Sun Pharmaceutical Industries Ltd.
Panacea Biotec Pharma Limited
Aurobindo Pharma Limited
JO Cosmetics Co., Ltd.
Apertus Pharmaceuticals
BRS Analytical Services, LLC
Unilever Manufacturing (US), Inc.
Lilly del Caribe, Inc
Eisai Company Ltd.
Astellas Pharma Inc.
Company Information

Name

Catalent Pharma Solutions LLC

FEI Number

1000110912

Address

160 S Pharma Dr, Morrisville, North Carolina 27560, United States

Country

United States

ID: 1080c7fd-2536-4ea5-9a11-18fc6317081b

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Contact
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🇪🇺+48 532-447-507
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