Drug factory · FDA FEI 1000110912

Catalent Pharma Solutions, LLC

160S Pharma Drive, Morrisville, NC, United States

Problems found, fixed voluntarily at FDA's last inspection, May 22, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

11 drug inspections on record since 2009: 6 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Anagrelide	Tests it	Takeda Pharmaceuticals America, Inc.	54092-063

Ended	Result	Program	Problems noted
May 22, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	1
Dec 15, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	4
Sep 28, 2020	Serious problems, FDA action	Drug Quality Assurance	5
Dec 20, 2019	No problems found	Drug Quality Assurance	—
Mar 4, 2019	No problems found	Drug Quality Assurance	—
Feb 1, 2019	No problems found	Bioresearch Monitoring	—
May 19, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 20, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 14, 2013	No problems found	Drug Quality Assurance	—
Nov 11, 2010	No problems found	Drug Quality Assurance	—
Nov 18, 2009	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures and laboratory control mechanisms are not followed.
Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed.
Test methods 21 CFR 211.165(e)
The accuracy of test methods have not been established.
Sterility/pyrogens - test methods written, followed 21 CFR 211.167(a)
Test procedures relative to appropriate laboratory testing for pyrogens are not written.

Design plans - Lack of or inadequate 21 CFR 820.30(b)
Design plans that describe or reference the design and development activities and define responsibility for implementation have not been established.
Design input - Lack of or inadequate procedures 21 CFR 820.30(c)
Procedures for design input have not been established.
Design output - Lack of or inadequate procedures 21 CFR 820.30(d)
Procedures for design output have not been adequately established.
Design verification - Lack of or inadequate procedures 21 CFR 820.30(f)
Procedures for design verification have not been adequately established.
Design validation- Lack of or inadequate procedures 21 CFR 820.30(g)
Procedures for design validation have not been adequately established.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Released Drug Products Area 21 CFR 211.42(c)(8)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the storage of drug products after release.

Registered with FDA for: analysis; manufacture.