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Lgm Pharma Solutions, Llc

United States See location details
Last FDA Action: Jan 24, 2025

This drug manufacturing facility is registered with the FDA by Lgm Pharma Solutions, Llc. ProPublica was able to identify at least 71 generic drugs that have been manufactured at this facility.

Facility Inspection History

The FDA is responsible for inspecting drug manufacturing facilities for violations of good manufacturing practices, such as a lack of documented drug quality testing or contaminated equipment. Below is a timeline of FDA inspections and outcomes for this facility assembled by ProPublica.

Note: ProPublica does not provide medical advice. Stopping your medication, doctors warn, can be dangerous. Please consult your doctor first if you have concerns. Read more
10 Known Inspections

The inspections we were able to locate using available FDA data do not include inspections in advance of the release of a new drug product.

6 Inspections Found Issues

When issues are observed, inspectors usually file an FDA 483 form with citations. In more serious cases, the FDA can issue warning letters or even ban the import of drugs from the facility.

  • Jan 24, 2025
    Jan 24, 2025
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Mar 1, 2024
    Mar 1, 2024
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    4 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Written procedures not established/followed
    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.
    Absence of Written Procedures
    There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Jan 31, 2020
    Jan 31, 2020
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Aug 17, 2018
    Aug 17, 2018
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    4 citations
    Failure to develop written procedures
    Written procedures have not been developed for the receipt and reporting to FDA of post marketing adverse drug experiences.
    Incomplete periodic safety report
    Not all periodic reports contained an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report.
    Failure to submit electronic format safety report
    Not all safety report submissions were made in an electronic format.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Dec 13, 2016
    Dec 13, 2016
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 11, 2014
    Jul 11, 2014
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    12 citations
    Equipment for Environmental Control
    Equipment for adequate control over temperature is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
    Cleaning / Sanitizing / Maintenance
    Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
    Quarantine of Rejected Components et. al.
    Rejected closures are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 5, 2011
    May 5, 2011
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Apr 22, 2010
    Apr 22, 2010
    Inspection

    The FDA determined this facility was in an acceptable state.

    This is the best possible outcome for an inspection. The FDA took no compliance action and ProPublica found no issues documented by inspectors.
  • Apr 2, 2010
    Apr 2, 2010
    Inspection With Issues

    The FDA ruled the facility was in an “unacceptable state of compliance.”

    Inspectors found serious issues at the facility, and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 28, 2009
    Jan 28, 2009
    Inspection With Issues

    The FDA found issues but determined the facility can correct them voluntarily.

    In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.

Drugs Manufactured Here

Below is a list of generic prescription drugs that we’ve been able to connect to this facility. Brand name and over-the-counter drugs, as well as labels we were unable to trace, are not included here.

Ascomp With Codeine

CompanyBreckenridge Pharmaceutical
Dosage
Butalbital
50mg
Aspirin
325mg
Blue, yellow capsule marked with B074
NDC: 51991-074-X

Ascomp With Codeine

CompanyLgm Pharma Solutions
Dosage
Butalbital
50mg
Aspirin
325mg
Yellow body, blue cap capsule marked with B 074
NDC: 79739-6094-1

Butal/apap/caffeine

CompanyDirect_rx
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 72189-600-X

Butalbital And Acetaminophen

CompanyOceanside Pharmaceuticals
Dosage
Butalbital
50mg
Acetaminophen
300mg
Yellowish round tablet marked with BA 300
NDC: 68682-306-01

Butalbital, Acetaminophen, And Caffeine

CompanyLgm Pharma Solutions
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 79739-7320-X

Butalbital, Acetaminophen, And Caffeine

CompanyAvkare
Dosage
Butalbital
50mg
Acetaminophen
300mg
Light blue body, light blue cap capsule marked with FIORICET
NDC: 42291-181-01

Butalbital, Acetaminophen, And Caffeine

CompanyActavis Pharma
Dosage
Butalbital
50mg
Acetaminophen
300mg
Light blue body, light blue cap capsule marked with FIORICET
NDC: 0591-2640-X

Butalbital, Acetaminophen, Caffeine

CompanyBryant Ranch Prepack
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 71335-1767-X

Butalbital, Acetaminophen, Caffeine

CompanyBryant Ranch Prepack
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 71335-1764-X

Butalbital, Acetaminophen, Caffeine

CompanyAvpak
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 50268-553-X

Butalbital, Acetaminophen, Caffeine

CompanyA-s Medication Solutions
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 50090-7042-X

Butalbital, Acetaminophen, Caffeine

CompanyProficient Rx Lp
Dosage
Butalbital
50mg
Acetaminophen
325mg
White round tablet marked with BAC 123
NDC: 71205-510-X

Frequently Asked Questions

What Do the Inspection Outcomes Mean?
These are the possible FDA compliance outcomes we highlight:
  • Import alert. This is rare and means drugs from this facility were banned from coming into the U.S. Specifically we are including alerts relating to FDA manufacturing standards for drug products. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages.
  • Warning letter. This is a disciplinary tool the FDA uses to lay out significant violations of federal requirements. The company has an opportunity to respond and/or provide its plans to correct the issues. The agency might later issue a “close-out letter” to say it has confirmed that issues raised in a previous warning letter were fixed. But that doesn’t always happen.
  • Unacceptable state of compliance. This means inspectors found serious issues at the facility and the agency ultimately recommended official compliance action. In cases like this, the FDA typically pauses the facility’s pending drug approvals. The agency classifies this as “official action indicated.”
  • Some issues found, but no further FDA action. This is very common. It means the FDA found issues but determined the facility can correct them voluntarily. In some cases, inspectors may have recommended a different (potentially more serious) classification, but the agency declined to pursue further enforcement at the time. The agency classifies this as “voluntary action indicated.”
  • Inspector documented issues. Inspectors can file notes summarizing deficiencies observed during an inspection using a 483 form. In some cases, we’re unable to connect a Form 483 to an FDA inspection designation, but we show that an inspector filed this form, perhaps as part of an inspection that was not included in the public inspection dashboard.
  • Acceptable state. This is common and the best possible outcome for an inspection. This means the FDA took no compliance action and ProPublica found no issues documented by inspectors. That doesn’t always mean no issues turned up. Sometimes, inspectors address concerns with management on site that they believe do not need to be documented on a 483. The agency classifies this as “no action indicated.”
There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.

How Did ProPublica Connect This Information?
We have written an in-depth methodology, but in short, we connected several FDA databases:
  • The Structured Product Labeling database.
  • The National Drug Code Directory.
  • The Electronic Drug Registration and Listing System.
  • Data from the agency’s inspection dashboard.
  • A spreadsheet of facility addresses we sued the FDA for, which connected them to drug application numbers.
  • Form 483 documents we received from a Freedom of Information Act Request.
ProPublica described the app and the methodology used to build it to the FDA, which did not comment. The agency previously told ProPublica that it doesn’t reveal where drugs are made on inspection reports to protect what it deemed confidential commercial information.

How Do I Report Incorrect Information?
If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].