Intas Pharmaceuticals Limited

Last FDA Action: Jul 12, 2024

Recent Compliance Action Read more

This drug manufacturing facility is registered with the FDA by Intas Pharmaceuticals Limited. ProPublica was able to identify at least 442 generic drugs that have been manufactured at this facility.

Facility Under Import Ban

This facility was on the FDA's import ban list last time we checked (November 2025), relating to failures in good manufacturing practices.

The following drug(s) were exempted from the ban at that time: Clonazepam Tablet, Azacitidine Injection, Mycophenolate Mofetil Capsule, Temsirolimus Injection Solution, Topotecan Solution Concentrate, Etoposide Injection, Bicalutamide Tablet, Tacrolimus Capsule, Temozolomide Capsule, Cisplatin Injection, Acetazolamide Capsule ER0F1, Carbidopa And Levodopa Tablet ER, Furosemide Injection, Topotecan Hydrochloride Injection Powder Lyophilized For Solution, Fulvestrant Injection, Anastrozole Tablet, Methotrexate Injection, Busulfan Injection, Mycophenolic Acid Tablet DR1F2, Naltrexone Hydrochloride Tablet, Capecitabine Tablet, Atropine Sulfate Solution, Mycophenolate Mofetil Tablet, Letrozole Tablet, Gemcitabine Injection Solution, Atropine Sulfate Injection, Quetiapine Fumarate Tablet ER

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.

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.

Jul 12, 2024

Jul 12, 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 21, 2023

Nov 21, 2023

Warning Letter

The FDA issued a warning letter laying out significant issues.

The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
View Warning Letter

View Warning Letter
Nov 14, 2023

Nov 14, 2023

Import Ban

The FDA banned the import of medications from this facility.

An import alert was issued for this facility, meaning the FDA had reason to believe products manufactured there violated FDA manufacturing standards and should not be allowed into the country.
May 12, 2023

May 12, 2023

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.
Aug 2, 2019

Aug 2, 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.

14 citations

Procedures not in writing, fully followed

The responsibilities and procedures applicable to the quality control unit are not in writing.
Air Supply

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
Environmental Monitoring System

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

View Inspector Notes
Inspector’s notes summarizing deficiencies observed during an inspection.
Dec 14, 2018

Dec 14, 2018

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.
Jun 8, 2018

Jun 8, 2018

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.
Jul 31, 2017

Jul 31, 2017

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 17, 2017

Feb 17, 2017

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.
Jun 17, 2016

Jun 17, 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.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Apr 7, 2015

Apr 7, 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.
Jun 21, 2013

Jun 21, 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.
May 19, 2012

May 19, 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.

ProPublica was unable to locate a 483 form detailing issues found in this inspection.
Oct 10, 2011

Oct 10, 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.
Nov 13, 2009

Nov 13, 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.

White to off white round tablet marked with AW

NDC: 16729-134-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.

Intas Pharmaceuticals Limited

Facility Under Import Ban

Facility Inspection History

The FDA determined this facility was in an acceptable state.

The FDA issued a warning letter laying out significant issues.

The FDA banned the import of medications from this facility.

An inspector documented issues at the facility.

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

14 citations

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

An inspector documented issues at the facility.

An inspector documented issues at the facility.

An inspector documented issues at the facility.

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

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

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

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

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

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

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?