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The Ritedose Corporation

United States See location details
Last FDA Action: Feb 28, 2025

This drug manufacturing facility is registered with the FDA by The Ritedose Corporation. ProPublica was able to identify at least 54 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
12 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.

  • Feb 28, 2025
    Feb 28, 2025
    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.
    3 citations
    Defined areas of adequate size for operations
    The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
    Validation lacking for sterile drug products
    Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
    Investigations of discrepancies, failures
    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Mar 22, 2022
    Mar 22, 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.
    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.
  • Apr 18, 2019
    Apr 18, 2019
    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 3, 2017
    Mar 3, 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.
    5 citations
    Following/documenting laboratory controls
    Established laboratory control mechanisms are not followed and documented at the time of performance.
    Lack of or inadequate organizational structure
    The organizational structure has not been adequately established and maintained to ensure that devices are designed and produced in accordance with 21 CFR 820.
    Management review - Lack of or inadequate procedures
    Procedures for management review are not complete.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 31, 2015
    Jul 31, 2015
    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 17, 2014
    Apr 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.
  • Nov 8, 2012
    Nov 8, 2012
    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.
  • Sep 9, 2011
    Sep 9, 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 6, 2011
    Jan 6, 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.
  • Sep 30, 2010
    Sep 30, 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 12, 2010
    Aug 12, 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.
  • Sep 18, 2009
    Sep 18, 2009
    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.

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.

Albuterol Sulfate

CompanyAmerican Health Packaging
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 60687-395-X

Albuterol Sulfate

CompanyCardinal Health 107
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 55154-2132-5

Albuterol Sulfate

CompanyA-s Medication Solutions
Dosage
2.5mg/3mL
Solution in a pouch (25mL)
NDC: 50090-0516-X

Albuterol Sulfate

CompanyMylan Pharmaceuticals
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 0378-8270-X

Albuterol Sulfate

CompanyMedical Purchasing Solutions
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 71872-7054-1

Albuterol Sulfate

CompanyNucare Pharmaceuticals
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 68071-3780-2

Albuterol Sulfate

CompanyCardinal Health 107
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 55154-4410-5

Albuterol Sulfate

CompanyRedpharm Drug
Dosage
1.25mg/3mL
Solution in a carton (25mL)
NDC: 67296-1863-7

Albuterol Sulfate

CompanyRedpharm Drug
Dosage
2.5mg/3mL
Solution in a ampule (25mL)
NDC: 67296-1698-X

Albuterol Sulfate

CompanyRemedyrepack
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 70518-3442-0

Albuterol Sulfate

CompanyRitedose Pharmaceuticals
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 76204-200-X

Albuterol Sulfate

CompanyPreferred Pharmaceuticals
Dosage
2.5mg/3mL
Solution in a ampule (3mL)
NDC: 68788-8399-2

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].