Sovereign Pharmaceuticals, LLC
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 7590 Sand Street, Fort Worth, Texas (TX) 76118, United States (USA)
- Operations here
- analysislabelmanufacturepackrelabelrepack
- FDA identifiers
- FEI 3003229412 · DUNS 623168267
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-05-12
- OAIDrug Quality Assurance2023-08-02
- OAIDrug Quality Assurance2022-04-22
- VAIDrug Quality Assurance2021-09-01
- VAIUnapproved and Misbranded Drugs2021-09-01
- VAIDrug Quality Assurance2019-12-12
- NAIDrug Quality Assurance2018-12-19
- VAIDrug Quality Assurance2018-01-12
- VAIDrug Quality Assurance2016-11-10
- VAIDrug Quality Assurance2016-01-08
- VAIDrug Quality Assurance2015-08-21
- VAIUnapproved and Misbranded Drugs2015-08-21
- NAIUnapproved and Misbranded Drugs2013-06-21
- VAIDrug Quality Assurance2013-06-21
- OAIDrug Quality Assurance2012-02-02
- OAIUnapproved and Misbranded Drugs2012-02-02
- VAIDrug Quality Assurance2010-05-24
- VAIDrug Quality Assurance2009-06-17
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan HydrobromideAcella Pharmaceuticals, LLC
- Doxycycline HyclateLarken Laboratories, Inc.
- hyoscyamine sulfateAcella Pharmaceuticals, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.