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Ascent Pharmaceuticals Inc

United States See location details
Last FDA Action: Aug 9, 2024

This drug manufacturing facility is registered with the FDA by Ascent Pharmaceuticals Inc. ProPublica was able to identify at least 562 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
9 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.

  • Aug 9, 2024
    Aug 9, 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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Sep 15, 2022
    Sep 15, 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.
    1 citation
    Failure to comply with REMS Implementation System
    An application holder did not comply with the audit plan and schedule described in the REMS, as required by your approved REMS Implementation System.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Oct 13, 2020
    Oct 13, 2020
    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 7, 2018
    Nov 7, 2018
    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.
  • Jul 27, 2018
    Jul 27, 2018
    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 21, 2018
    Feb 21, 2018
    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 9, 2015
    Nov 9, 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.
  • Sep 26, 2013
    Sep 26, 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.
  • Dec 6, 2012
    Dec 6, 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.
    3 citations
    Washing and toilet facilities are deficient
    Washing and toilet facilities lack hot and cold water.
    Following/documenting laboratory controls
    Established laboratory control mechanisms are not followed and documented at the time of performance.
    Samples (various types) representative, identified properly
    Samples taken to determine conformance to appropriate written specifications for the acceptance of each lot within each shipment of components are not representative.
    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.

Aripiprazole

CompanyExelan Pharmaceuticals
Dosage
2mg
Green rectangle tablet marked with T 44
NDC: 76282-044-X

Aripiprazole

CompanyExelan Pharmaceuticals
Dosage
5mg
Blue rectangle tablet marked with T 45
NDC: 76282-045-X

Aripiprazole

CompanyExelan Pharmaceuticals
Dosage
10mg
Pink rectangle tablet marked with T 46
NDC: 76282-046-X

Aripiprazole

CompanyExelan Pharmaceuticals
Dosage
30mg
Pink round tablet marked with T 49
NDC: 76282-049-X

Aripiprazole

CompanyXlcare Pharmaceuticals
Dosage
30mg
Light pink to pink round tablet marked with T 49
NDC: 72865-185-X

Aripiprazole

CompanyCamber Pharmaceuticals
Dosage
2mg
Light green to green rectangle tablet marked with T 44
NDC: 31722-919-X

Aripiprazole

CompanyCamber Pharmaceuticals
Dosage
5mg
Light blue to blue rectangle tablet marked with T 45
NDC: 31722-920-X

Aripiprazole

CompanyCamber Pharmaceuticals
Dosage
20mg
White to off-white round tablet marked with T 48
NDC: 31722-923-X

Aripiprazole

CompanyCamber Pharmaceuticals
Dosage
30mg
Light pink to pink round tablet marked with T 49
NDC: 31722-924-X

Aripiprazole

CompanyXlcare Pharmaceuticals
Dosage
30mg
Light pink to pink round tablet marked with I 99
NDC: 72865-158-X

Aripiprazole

CompanyXlcare Pharmaceuticals
Dosage
2mg
Light green to green rectangle tablet marked with I 94
NDC: 72865-153-X

Aripiprazole

CompanyXlcare Pharmaceuticals
Dosage
10mg
Light pink to pink rectangle tablet marked with I 96
NDC: 72865-155-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].