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Zydus Lifesciences Limited

India See location details
Last FDA Action: Aug 5, 2022

This drug manufacturing facility is registered with the FDA by Zydus Lifesciences Limited. ProPublica was able to identify at least 836 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.
10 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.

  • Aug 5, 2022
    Aug 5, 2022
    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.
    4 citations
    Procedures To Be in Writing
    Written procedures are lacking which describe in sufficient detail the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.
    Absence of Written Procedures
    There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • May 3, 2019
    May 3, 2019
    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.
    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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 22, 2019
    Mar 22, 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.
  • Feb 9, 2018
    Feb 9, 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.
  • Feb 16, 2017
    Feb 16, 2017
    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 5, 2014
    Sep 5, 2014
    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.
    4 citations
    Extent of discrepancy, failure investigations
    Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
    Complaint Handling Procedure
    Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
    Written record of complaint to include findings, follow-up
    Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 19, 2013
    Aug 19, 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.
  • Feb 23, 2012
    Feb 23, 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.
  • Feb 3, 2011
    Feb 3, 2011
    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.
  • Feb 6, 2009
    Feb 6, 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.

Acetazolamide

CompanyZydus Lifesciences
Dosage
500mg
Yellow, white capsule marked with XYL 34
NDC: 65841-762-X

Acyclovir

CompanyZydus Lifesciences
Dosage
Acyclovir Sodium
50mg/mL
Injection, solution in a vial, single-use (10mL)
NDC: 70771-1383-X

Acyclovir

CompanyZydus Lifesciences
Dosage
Acyclovir Sodium
50mg/mL
Injection, solution in a vial, single-use (20mL)
NDC: 70771-1384-X

Acyclovir

CompanyZydus Pharmaceuticals (usa)
Dosage
Acyclovir Sodium
50mg/mL
Injection, solution in a vial, single-use (10mL)
NDC: 68382-048-X

Acyclovir

CompanyZydus Pharmaceuticals (usa)
Dosage
Acyclovir Sodium
50mg/mL
Injection, solution in a vial, single-use (20mL)
NDC: 68382-049-X

Ambrisentan

CompanyQuallent Pharmaceuticals Health
Dosage
10mg
Off white oval tablet, film coated marked with 1180
NDC: 82009-142-30

Ambrisentan

CompanyQuallent Pharmaceuticals Health
Dosage
5mg
Pink round tablet, film coated marked with 1179
NDC: 82009-141-30

Amiodarone Hydrochloride

CompanyZydus Lifesciences
Dosage
200mg
White to off-white round tablet marked with ZE 65
NDC: 65841-631-X

Amiodarone Hydrochloride

CompanyZydus Lifesciences
Dosage
400mg
Pale yellow to yellow round tablet marked with 2 98
NDC: 65841-841-06

Amiodarone Hydrochloride

CompanyZydus Pharmaceuticals Usa
Dosage
400mg
Pale yellow to yellow round tablet marked with 2 98
NDC: 68382-298-06

Amiodarone Hydrochloride

CompanyMckesson Corporation Dba Sky Packaging
Dosage
200mg
White to off- white round tablet marked with ZE 65
NDC: 63739-051-10

Amiodarone Hydrochloride

CompanyZydus Lifesciences
Dosage
100mg
Off-white round tablet marked with 297
NDC: 65841-840-06

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.

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].