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Amneal Pharmaceuticals, Llc

United States See location details
Last FDA Action: Feb 8, 2024

This drug manufacturing facility is registered with the FDA by Amneal Pharmaceuticals Of New York, Llc. ProPublica was able to identify at least 77 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.

4 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 8, 2024
    Feb 8, 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.
  • Nov 18, 2022
    Nov 18, 2022

    An inspector documented issues at the facility.

    We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Feb 21, 2019
    Feb 21, 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.
    3 citations
    Incoming material area
    Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the receipt, identification, storage, and withholding from use of components and drug product containers pending sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
    Reports of Analysis (Components)
    Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
    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.
  • Jul 27, 2017
    Jul 27, 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.
  • Oct 16, 2015
    Oct 16, 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.
  • Oct 17, 2013
    Oct 17, 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.
  • Nov 15, 2011
    Nov 15, 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.
  • Jul 27, 2010
    Jul 27, 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.
  • Dec 17, 2008
    Dec 17, 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.
    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.

Aminocaproic Acid

CompanyAmneal Pharmaceuticals Ny
Dosage
0.25g/mL
Natural and artificial raspberry flavor-flavored solution in a bottle, plastic (236.5mL)
NDC: 69238-1596-X

Amlodipine

CompanyAmneal Pharmaceuticals Ny
Dosage
Amlodipine Benzoate
1mg/mL
White to off-white suspension in a bottle (150mL)
NDC: 69238-2026-7

Aripiprazole

CompanyAmneal Pharmaceuticals
Dosage
1mg/mL
Clear to pale yellow natural orange, cream and other natural and artificial flavors-flavored solution in a bottle (150mL)
NDC: 65162-893-74

Atovaquone

CompanyAmneal Pharmaceuticals
Dosage
750mg/5mL
Yellow citrus-flavored suspension in a bottle (210mL)
NDC: 65162-693-88

Azelastine Hydrochloride

CompanyAvkare
Dosage
1mg/mL
White (clear) spray, metered in a bottle, spray (30mL)
NDC: 42291-094-30

Azelastine Hydrochloride

CompanyAmneal Pharmaceuticals
Dosage
1mg/mL
White (clear) spray, metered in a bottle, spray (30mL)
NDC: 65162-676-84

Cetirizine Hydrochloride

CompanyAmneal Pharmaceuticals
Dosage
5mg/5mL
Clear to pale yellow grape-flavored solution in a bottle (118mL)
NDC: 65162-684-X

Clindamycin Palmitate Hydrochloride (pediatric)

CompanyAmneal Pharmaceuticals
Dosage
Clindamycin Palmitate Hydrochloride
75mg/5mL
White (clear) cherry-flavored powder, for solution in a bottle (100mL)
NDC: 65162-468-19

Clobazam

CompanyPrecision Dose
Dosage
2.5mg/mL
Off-white berry-flavored suspension in a syringe, plastic (4mL)
NDC: 68094-074-X

Clobazam

CompanyAmneal Pharmaceuticals Ny
Dosage
2.5mg/mL
Off-white berry-flavored suspension in a bottle, glass (120mL)
NDC: 69238-1535-2

Diclofenac Sodium

CompanyDirect_rx
Dosage
1.6%
Solution in a bottle (150mL)
NDC: 72189-527-05

Diclofenac Sodium

CompanyAdvanced Rx Of Tennessee
Dosage
1.6%
Solution in a bottle, dropper (150mL)
NDC: 80425-0368-1

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].