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Trirx Huntsville Pharmaceutical Services, Llc

United States See location details
Last FDA Action: Aug 11, 2023

This drug manufacturing facility is registered with the FDA by Trirx Huntsville Pharmaceutical Services, Llc. ProPublica was able to identify at least 12 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
13 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.

7 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.

  • Aug 11, 2023
    Aug 11, 2023
    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 1, 2022
    Apr 1, 2022
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Apr 21, 2016
    Apr 21, 2016
    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.
  • Dec 19, 2014
    Dec 19, 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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Aug 1, 2014
    Aug 1, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 17, 2014
    Jul 17, 2014
    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.
  • May 30, 2013
    May 30, 2013
    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.
  • Mar 21, 2013
    Mar 21, 2013
    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.
  • Dec 7, 2011
    Dec 7, 2011
    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.
  • Apr 14, 2011
    Apr 14, 2011
    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.
    3 citations
    Written Procedures Not Followed
    Written procedures are not followed for the receipt and identification of drug product containers and closures.
    Control procedures to monitor and validate performance
    Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
    Extent of discrepancy, failure investigations
    Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Dec 10, 2010
    Dec 10, 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.
  • Mar 19, 2010
    Mar 19, 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.
  • Aug 21, 2009
    Aug 21, 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.
    5 citations
    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.
    Cleaning SOPs/schedules
    Procedures for the cleaning and maintenance of equipment are deficient regarding maintenance and cleaning schedules, including, where appropriate, sanitizing schedules.
    Procedures for non-sterile drug products
    Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
    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.

Clindamycin Phosphate

CompanyI3 Pharmaceuticals
Dosage
1%
Solution in a applicator (1mL)
NDC: 72319-696-60

Hydrocodone Bitartrate And Acetaminophen

CompanyGenus Lifesciences
Dosage
Hydrocodone Bitartrate
7.5mg/15mL
Acetaminophen
325mg/15mL
Red tropical fruit punch-flavored solution in a bottle (473mL)
NDC: 64950-343-16

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral

CompanyA-s Medication Solutions
Dosage
Dextromethorphan Hydrobromide
15mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Yellow orange, pineapple-flavored solution in a bottle (118mL)
NDC: 50090-6585-0

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

CompanyNucare Pharmaceuticals
Dosage
Dextromethorphan Hydrobromide
15mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Yellow orange, pineapple-flavored solution in a bottle (118mL)
NDC: 68071-3551-4

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

CompanyPreferred Pharmaceuticals
Dosage
Dextromethorphan Hydrobromide
15mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Yellow orange, pineapple-flavored solution in a bottle (118mL)
NDC: 68788-8100-1

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

CompanySlate Run Pharmaceuticals
Dosage
Dextromethorphan Hydrobromide
15mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Yellow orange, pineapple-flavored solution in a bottle (118mL)
NDC: 70436-155-X

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

CompanyAtlantic Biologicals
Dosage
Dextromethorphan Hydrobromide
15mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Yellow orange, pineapple-flavored solution in a cup, unit-dose (5mL)
NDC: 17856-0155-1

Promethazine Hydrochloride And Dextromethorphan Hydrobromide Oral Solution

CompanyProficient Rx Lp
Dosage
Dextromethorphan Hydrobromide
15mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Yellow orange, pineapple-flavored solution in a bottle (118mL)
NDC: 71205-654-04

Promethazine Vc With Codeine Oral Solution

CompanyPai Holdings
Dosage
Codeine Phosphate
10mg/5mL
Promethazine Hydrochloride
6.25mg/5mL
Clear-reddish strawberry-flavored solution in a bottle (473mL)
NDC: 0121-0925-16

Sucralfate

CompanyTrupharma
Dosage
1g/10mL
Pink cherry-flavored suspension in a bottle (473mL)
NDC: 52817-840-16

Sucralfate

CompanyRichmond Pharmaceuticals
Dosage
1g/10mL
Pink berry-flavored suspension in a bottle (420mL)
NDC: 54738-005-42

Sucralfate

CompanyTorrent Pharmaceuticals
Dosage
1g/10mL
Pink berry-flavored suspension in a bottle (420mL)
NDC: 13668-754-42

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].