ProPublica
Donate
New Search

Amneal Pharmaceuticals Of New York, Llc

United States See location details
Last FDA Action: Jun 7, 2023

This drug manufacturing facility is registered with the FDA by Amneal Pharmaceuticals Of New York, Llc. ProPublica was able to identify at least 479 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
13 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.

  • Jun 7, 2023
    Jun 7, 2023
    Inspection With Issues

    The FDA determined this facility was in an acceptable state, though an inspector documented issues.

    The FDA ultimately considered the facility to be in an acceptable state of compliance, which is the best possible outcome for an inspection. It’s impossible to know exactly what happened in this case, but an inspector filed a 483 report documenting issues, possibly as a part of a concurrent inspection that we don’t have an outcome for.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Dec 20, 2019
    Dec 20, 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.
  • 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.
  • Jan 30, 2019
    Jan 30, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 10, 2018
    Jul 10, 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.
  • May 24, 2017
    May 24, 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.
    3 citations
    Cleaning SOPs/equipment protection
    Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment from contamination prior to use.
    Calibration/Inspection/Checking not done
    Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
    Control procedures to monitor and validate performance
    Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 16, 2014
    May 16, 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.
  • Jul 3, 2013
    Jul 3, 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.
    3 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    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.
    Establishment of time limitations
    Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 3, 2012
    Jul 3, 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.
  • Mar 10, 2011
    Mar 10, 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.
  • Aug 5, 2010
    Aug 5, 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.
  • Feb 5, 2010
    Feb 5, 2010
    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.
  • Jun 22, 2009
    Jun 22, 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.

Abiraterone Acetate

CompanyAmneal Pharmaceuticals Ny
Dosage
250mg
White to off-white oval tablet marked with AN65
NDC: 69238-1165-7

Abiraterone Acetate

CompanyAmneal Pharmaceuticals Ny
Dosage
500mg
Purple oval tablet marked with 1754
NDC: 69238-1754-6

Abiraterone Acetate

CompanyAvkare
Dosage
250mg
White to off-white oval tablet marked with AN65
NDC: 42291-024-12

Acebutolol Hydrochloride

CompanyAmneal Pharmaceuticals
Dosage
400mg
Purple (lavender), bright orange capsule marked with Amneal 670
NDC: 65162-670-X

Acebutolol Hydrochloride

CompanyAmneal Pharmaceuticals
Dosage
200mg
Purple (lavender), bright orange capsule marked with Amneal 669
NDC: 65162-669-X

Acetaminophen And Codeine

CompanyAsclemed Usa
Dosage
Acetaminophen
300mg
Codeine Phosphate
30mg
White round tablet marked with IP33 3
NDC: 76420-103-X

Acetaminophen And Codeine

CompanyProficient Rx Lp
Dosage
Acetaminophen
300mg
Codeine Phosphate
30mg
White round tablet marked with IP33 3
NDC: 63187-491-X

Acetaminophen And Codeine

CompanyRedpharm Drug
Dosage
Acetaminophen
300mg
Codeine Phosphate
30mg
White round tablet marked with IP33 3
NDC: 67296-1772-X

Acetaminophen And Codeine

CompanyRemedyrepack
Dosage
Acetaminophen
300mg
Codeine Phosphate
30mg
White round tablet marked with IP33 3
NDC: 70518-3980-0

Acetaminophen And Codeine

CompanyAmneal Pharmaceuticals
Dosage
Acetaminophen
300mg
Codeine Phosphate
30mg
White round tablet marked with IP33 3
NDC: 65162-033-X

Alosetron Hydrochloride

CompanyAmneal Pharmaceuticals
Dosage
0.5mg
White oval tablet, film coated marked with AN248
NDC: 65162-248-X

Alosetron Hydrochloride

CompanyAmneal Pharmaceuticals
Dosage
1mg
Light blue oval tablet, film coated marked with AN249
NDC: 65162-249-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].