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Guardian Drug Company, Inc.

United States See location details
Last FDA Action: Nov 7, 2024

This drug manufacturing facility is registered with the FDA by Guardian Drug Company, Inc.. ProPublica was able to identify at least 14 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
8 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.

  • Nov 7, 2024
    Nov 7, 2024
    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.
  • Feb 17, 2022
    Feb 17, 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.
  • Nov 6, 2017
    Nov 6, 2017
    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.
  • Aug 15, 2014
    Aug 15, 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.
  • Jun 8, 2012
    Jun 8, 2012
    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 2, 2012
    Mar 2, 2012
    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.
    1 citation
    Investigations of discrepancies, failures
    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 18, 2011
    Feb 18, 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.
    4 citations
    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.
    Scientifically sound laboratory controls
    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
    Lack of written stability program
    There is no written testing program designed to assess the stability characteristics of drug products.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 28, 2008
    Oct 28, 2008
    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.
    1 citation
    Written record of investigation incomplete
    Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
    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.

Diatrizoate Meglumine And Diatrizoate Sodium

CompanyGuardian Drug Company
Dosage
Diatrizoate Meglumine
660mg/mL
Diatrizoate Sodium
100mg/mL
Lemon-flavored solution in a bottle, plastic (120mL)
NDC: 53041-688-03

Diatrizoate Meglumine And Diatrizoate Sodium

CompanyGuardian Drug Company
Dosage
Diatrizoate Meglumine
660mg/mL
Diatrizoate Sodium
100mg/mL
Lemon-flavored solution in a bottle, glass (30mL)
NDC: 53041-690-X

Furosemide

CompanyIpca Laboratories
Dosage
20mg
White round tablet marked with RE 22
NDC: 83980-002-X

Furosemide

CompanyIpca Laboratories
Dosage
40mg
White round tablet marked with RE 23
NDC: 83980-003-X

Furosemide

CompanyIpca Laboratories
Dosage
80mg
White round tablet marked with RE 24
NDC: 83980-004-X

Furosemide

CompanyCoupler
Dosage
20mg
White round tablet marked with RE 22
NDC: 67046-1589-3

Hydroxychloroquine Sulfate

CompanyIpca Laboratories
Dosage
200mg
White capsule-shaped tablet, film coated marked with HCQS
NDC: 83980-001-X

Hydroxychloroquine Sulfate

CompanyCoupler
Dosage
200mg
White capsule-shaped tablet, film coated marked with HCQS
NDC: 67046-1523-3

Mucus Relief

CompanyBryant Ranch Prepack
Dosage
Guaifenesin
600mg
White capsule-shaped tablet, extended release marked with G233
NDC: 71335-2642-X

Ondansetron

CompanyGolden State Medical Supply
Dosage
Ondansetron Hydrochloride
8mg
Yellow oval tablet marked with 8 NO
NDC: 51407-004-X

Ondansetron

CompanyGolden State Medical Supply
Dosage
Ondansetron Hydrochloride
4mg
White oval tablet marked with 4 NO
NDC: 51407-003-X

Potassium Chloride

CompanyGuardian Drug Company
Dosage
20meq/15mL
Orange orange-flavored solution in a bottle (473mL)
NDC: 53041-681-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].