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American Regent, Inc.

United States See location details
Last FDA Action: Jul 20, 2023

This drug manufacturing facility is registered with the FDA by American Regent, Inc.. ProPublica was able to identify at least 13 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
7 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.

5 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.

  • Jul 20, 2023
    Jul 20, 2023
    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.
  • Mar 8, 2019
    Mar 8, 2019
    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.
    2 citations
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    Failure to meet specifications
    An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Aug 18, 2017
    Aug 18, 2017
    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, 2016
    Dec 7, 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.
    3 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Buildings not maintained in good state of repair
    Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
    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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 4, 2014
    Apr 4, 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.
  • Sep 30, 2011
    Sep 30, 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.
  • Jan 23, 2009
    Jan 23, 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.

Betamethasone Sodium Phosphate And Betamethasone Acetate

CompanyAmerican Regent
Dosage
6mg/ml
Injection, suspension in a vial, multi-dose (5mL)
NDC: 0517-0791-01

Betamethasone Sodium Phosphate And Betamethasone Acetate

CompanyAsclemed Usa
Dosage
6mg/ml
Injection, suspension in a vial, multi-dose (5mL)
NDC: 76420-007-05

Betamethasone Sodium Phosphate And Betamethasone Acetate

CompanyAmerican Regent
Dosage
6mg/ml
Injection, suspension in a vial, multi-dose (5mL)
NDC: 0517-0799-01

Betamethasone Sodium Phosphate And Betamethasone Acetate

CompanyAmerican Regent
Dosage
6mg/ml
Injection, suspension in a vial, multi-dose (5mL)
NDC: 0517-0720-01

Dicyclomine Hydrochloride

CompanyAmerican Regent
Dosage
20mg/2mL
Injection, solution in a vial, single-dose (2mL)
NDC: 0517-1980-X

Epinephrine

CompanyAmerican Regent
Dosage
1mg/mL
Injection in a vial (1mL)
NDC: 0517-3030-01

Fomepizole

CompanyAmerican Regent
Dosage
1g/mL
Injection, solution in a vial (1.5mL)
NDC: 0517-0710-88

Fomepizole

CompanyAmerican Regent
Dosage
1g/mL
Injection, solution in a vial (1.5mL)
NDC: 0517-0710-01

Methylergonovine Maleate

CompanyAmerican Regent
Dosage
0.2mg/mL
Injection, solution in a vial, single-dose (1mL)
NDC: 0517-0740-X

Nicardipine Hydrochloride

CompanyAmerican Regent
Dosage
2.5mg/mL
Injection, solution in a vial (10mL)
NDC: 0517-0735-X

Ofloxacin

CompanyAmerican Regent
Dosage
0.3%
Solution/ drops in a bottle (10mL)
NDC: 0517-0761-01

Tranexamic Acid

CompanyAmerican Regent
Dosage
100mg/mL
Injection, solution in a vial, glass (10mL)
NDC: 0517-0960-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].