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Aurobindo Pharma Limited

India See location details
Last FDA Action: Jul 21, 2023

This drug manufacturing facility is registered with the FDA by Aurobindo Pharma Limited. ProPublica was able to identify at least 1481 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
12 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 21, 2023
    Jul 21, 2023
    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.
    3 citations
    Sanitation--buildings not clean, free of infestation
    Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
    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.
    Following/documenting laboratory controls
    Established laboratory control mechanisms are not followed and documented at the time of performance.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Jul 5, 2019
    Jul 5, 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.
  • May 24, 2019
    May 24, 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.
    10 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Buildings of Suitable Size, Construction, Location
    Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Aug 10, 2018
    Aug 10, 2018
    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
    Failure to develop written procedures
    Written procedures have not been developed for the receipt and reporting to FDA of post marketing adverse drug experiences.
    Incomplete periodic safety report
    Not all periodic reports contained an FDA Form 3500A for each adverse drug experience not reported as a post marketing 15-day Alert report.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 18, 2017
    Apr 18, 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.
    6 citations
    Authority lacking to review records, investigate errors
    The quality control unit lacks authority to fully investigate errors that have occurred.
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Deviations from laboratory control requirements
    Deviations from written specifications and test procedures are not recorded and justified.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 29, 2016
    Jan 29, 2016
    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.
  • Jun 26, 2015
    Jun 26, 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.
  • Mar 2, 2012
    Mar 2, 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.
  • Sep 8, 2011
    Sep 8, 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.
    1 citation
    Mix-up
    An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning an incident that caused a drug product or its labeling to be applied to another article.
  • Sep 24, 2010
    Sep 24, 2010
    Inspection With Issues

    The FDA ruled the facility was in an “unacceptable state of compliance.”

    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. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 22, 2009
    Oct 22, 2009
    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, 2009
    Jan 30, 2009
    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.

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.

Abacavir

CompanyAmerican Health Packaging
Dosage
Abacavir Sulfate
300mg
Yellow capsule-shaped tablet, film coated marked with D 88
NDC: 68084-021-X

Abacavir

CompanyAurobindo Pharma
Dosage
Abacavir Sulfate
300mg
Yellow capsule-shaped tablet, film coated marked with D 88
NDC: 65862-073-60

Abacavir

CompanyMajor Pharmaceuticals
Dosage
Abacavir Sulfate
300mg
Yellow capsule-shaped tablet, film coated marked with D 88
NDC: 0904-6874-X

Abacavir

CompanyRising Pharma Holdings
Dosage
Abacavir Sulfate
20mg/mL
Yellow banana, strawberry-flavored solution in a bottle (240mL)
NDC: 64980-405-24

Abacavir

CompanyAurobindo Pharma
Dosage
Abacavir Sulfate
20mg/mL
Yellow banana, strawberry-flavored solution in a bottle (240mL)
NDC: 65862-089-24

Abacavir And Lamivudine

CompanyAurobindo Pharma
Dosage
Abacavir Sulfate
600mg
Lamivudine
300mg
Orange capsule-shaped tablet, film coated marked with H 27
NDC: 65862-335-X

Acetazolamide

CompanyAurobindo Pharma
Dosage
125mg
White to off white round tablet marked with ACE 125
NDC: 59651-905-01

Acetazolamide

CompanyAurobindo Pharma
Dosage
250mg
White to off white round tablet marked with ACE 250
NDC: 59651-906-01

Alendronate Sodium

CompanyA-s Medication Solutions
Dosage
35mg
White to off-white oval tablet marked with F 19
NDC: 50090-5474-0

Alendronate Sodium

CompanyRising Pharma Holdings
Dosage
35mg
White to off-white oval tablet marked with F 19
NDC: 64980-341-X

Alendronate Sodium

CompanyAurobindo Pharma
Dosage
35mg
White to off-white oval tablet marked with F 19
NDC: 65862-328-X

Alendronate Sodium

CompanyAurobindo Pharma
Dosage
70mg
White to off-white oval tablet marked with F 21
NDC: 65862-329-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].