LGM Pharma Solutions, 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
- 17802 Gillette Avenue, Irvine, California (CA) 92614, United States (USA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3017140477 · DUNS 117549200
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- NAIBioresearch Monitoring2025-01-24
- VAIDrug Quality Assurance2024-03-01
- NAIDrug Quality Assurance2020-01-31
- VAIBioresearch Monitoring2018-08-17
- VAIDrug Quality Assurance2016-12-13
- VAIDrug Quality Assurance2014-07-11
- NAIDrug Quality Assurance2011-05-05
- NAIDrug Quality Assurance2010-04-22
- OAIDrug Quality Assurance2010-04-02
- OAIUnapproved and Misbranded Drugs2010-04-02
- VAIDrug Quality Assurance2009-01-28
Drugs this plant is listed as making
20 distinct drugs across 30 products name this site in their FDA label.
- Butalbital and Acetaminophen tabletsOceanside Pharmaceuticals
- Butalbital, Acetaminophen, and CaffeineLgm Pharma Solutions, Llc
- Butalbital, Acetaminophen, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.
- Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateLgm Pharma Solutions, Llc
- Butalbital, Aspirin, and CaffeineLgm Pharma Solutions, Llc
- Butalbital, Aspirin, Cafeine, and Codeine PhosphateLgm Pharma Solutions, Llc
- Butalbital, Aspirin, Caffeine and Codeine PhosphateBreckenridge Pharmaceutical, Inc.
- ChenodiolTravere Therapeutics
- codeine phosphate and chlorpheniramine maleateMainpointe Pharmaceuticals
- GlycopyrrolateLgm Pharma Solutions, Llc
- Mecamylamine HydrochlorideVyera Pharmaceuticals, LLC
- methscopolamine bromideBreckenridge Pharmaceutical, Inc.
- NabumetoneLgm Pharma Solutions, Llc
- OxcarbazepineBreckenridge Pharmaceutical, Inc.
- Potassium Phosphate, MonobasicBeach Products, Inc.
- Potassium Phosphate, Monobasic and Sodium Phosphate, Monobasic, AnhydrousBeach Products, Inc.
- Sodium Phosphate, Dibasic, Anhydrous, Potassium Phosphate, Monobasic, and Sodium Phosphate, Monobasic, MonohydrateBeach Products, Inc.
- UrsodiolFH2 Pharma LLC
- UsodiolLgm Pharma Solutions, 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.