Drug factory · FDA FEI 3003229412

Sovereign Pharmaceuticals, LLC

7590 Sand Street, Fort Worth, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, May 12, 2025.

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

18 drug inspections on record since 2009: 2 with no problems, 12 with problems fixed voluntarily, 4 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Baclofen	Repackages it	Acella Pharmaceuticals, LLC	42192-631
Doxycycline	Makes it	Larken Laboratories, Inc.	68047-714

Ended	Result	Program	Problems noted
May 12, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	4
Aug 2, 2023	Serious problems, FDA action	Drug Quality Assurance	—
Apr 22, 2022	Serious problems, FDA action	Drug Quality Assurance	4
Sep 1, 2021	Problems found, fixed voluntarily	Unapproved and Misbranded Drugs	6
Sep 1, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	6
Dec 12, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	3
Dec 19, 2018	No problems found	Drug Quality Assurance	—
Jan 12, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 10, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 8, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 21, 2015	Problems found, fixed voluntarily	Unapproved and Misbranded Drugs	6
Aug 21, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	6
Jun 21, 2013	No problems found	Unapproved and Misbranded Drugs	4
Jun 21, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	4
Feb 2, 2012	Serious problems, FDA action	Unapproved and Misbranded Drugs	16
Feb 2, 2012	Serious problems, FDA action	Drug Quality Assurance	16
May 24, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jun 17, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	3

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

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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.
Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Approval and review of procedures 21 CFR 211.100(a)
Written procedures are not drafted, reviewed and approved by the appropriate organizational units.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans designed to assure that components and in-process materials conform to appropriate standards of identity, strength, quality and purity.
Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
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.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete instructions.
Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete instructions.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include complete labeling control records, specimen and copy of labeling.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
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.

Registered with FDA for: analysis; label; manufacture; pack; relabel; repack.