Amneal Pharmaceuticals Of New York, Llc

Last FDA Action: Feb 3, 2020

This drug manufacturing facility is registered with the FDA by Amneal Pharmaceuticals Of New York, Llc. ProPublica was able to identify at least 133 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

11 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.

7 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 3, 2020

Feb 3, 2020

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 18, 2019

Mar 18, 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.

View Inspector Notes
Inspector’s notes summarizing deficiencies observed during an inspection.

1 citation

Storage under appropriate conditions

Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.

View Inspector Notes
Inspector’s notes summarizing deficiencies observed during an inspection.
Apr 11, 2017

Apr 11, 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.

1 citation

Clothing appropriate for duties performed

Clothing of personnel engaged in the packing and holding of drug products is not appropriate for the duties they perform.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Aug 9, 2016

Aug 9, 2016

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

Late submission of annual safety reports

Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application.
Late submission of quarterly safety reports

Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter.
Timely submission

An annual report was not submitted within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Mar 16, 2015

Mar 16, 2015

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 7, 2014

Feb 7, 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.
May 15, 2012

May 15, 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

Complaint Handling Procedure

Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Oct 29, 2010

Oct 29, 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.
May 26, 2010

May 26, 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.
Nov 24, 2009

Nov 24, 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.
Aug 18, 2009

Aug 18, 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.

2 citations

Procedures not in writing, fully followed

The responsibilities and procedures applicable to the quality control unit are not in writing.
Contamination, chemical or physical change, deterioration

An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

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.

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

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

Alprazolam

CompanyAmneal Pharmaceuticals

Dosage

0.5mg

Green round tablet, extended release marked with IP 9

NDC: 65162-809-X

Alprazolam

CompanyAmneal Pharmaceuticals

Dosage

1mg

Yellow round tablet, extended release marked with IP 10

NDC: 65162-810-X

Alprazolam

CompanyAmneal Pharmaceuticals

Dosage

2mg

Blue round tablet, extended release marked with IP 12

NDC: 65162-812-X

Alprazolam

CompanyAmneal Pharmaceuticals

Dosage

3mg

White round tablet, extended release marked with IP 13

NDC: 65162-813-X

Amlodipine Besylate

CompanyAmneal Pharmaceuticals

Dosage

10mg

White round tablet marked with IP 8

NDC: 65162-008-X

Amlodipine Besylate

CompanyAmneal Pharmaceuticals

Dosage

2.5mg

White round tablet marked with IP 6

NDC: 65162-006-X

Amlodipine Besylate

CompanyAmneal Pharmaceuticals

Dosage

5mg

White round tablet marked with IP 7

NDC: 65162-007-X

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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.

What if I Find Something Concerning?

ProPublica does not provide medical advice. Keep in mind that if you turn up a troubling inspection report, it doesn’t necessarily mean that your drug is compromised. Doctors and pharmacists advise that you not stop taking your medications. Instead, you should talk to your health care provider about any concerns.

There are often different manufacturers of the same generic drug, and which manufacturer you get can depend on the pharmacy where you shop and what it has in stock. Changing the pharmacy where you fill your prescription might mean you can get a generic made by a different manufacturer.

The FDA maintains a database known as the FDA Adverse Event Reporting System that tracks reports about potential drug-quality problems and sudden and unexpected health conditions among consumers. Both health care professionals and consumers can report problems.

Although we cannot offer medical advice, our reporting team wants to hear from you. Please fill out this form to let us know what you find. We may follow up with future reporting.

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.

Amneal Pharmaceuticals Of New York, Llc

Facility Inspection History

The FDA determined this facility was in an acceptable state.

The FDA found issues but determined the facility can correct them voluntarily.

1 citation

The FDA found issues but determined the facility can correct them voluntarily.

1 citation

The FDA found issues but determined the facility can correct them voluntarily.

3 citations

The FDA determined this facility was in an acceptable state.

The FDA found issues but determined the facility can correct them voluntarily.

The FDA found issues but determined the facility can correct them voluntarily.

1 citation

The FDA determined this facility was in an acceptable state.

The FDA determined this facility was in an acceptable state.

The FDA found issues but determined the facility can correct them voluntarily.

The FDA found issues but determined the facility can correct them voluntarily.

2 citations

Drugs Manufactured Here

Frequently Asked Questions

What Do the Inspection Outcomes Mean?

What if I Find Something Concerning?

How Did ProPublica Connect This Information?

How Do I Report Incorrect Information?