Skip to content
ProPublica Donate
ProPublica Donate
New Search

Kindeva Drug Delivery L.p.

United States See location details
Last FDA Action: Jul 28, 2021

This drug manufacturing facility is registered with the FDA by Kindeva Drug Delivery L.p.. ProPublica was able to identify at least 19 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.

  • Jul 28, 2021
    Jul 28, 2021
    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 25, 2019
    Jan 25, 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.
    2 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Failing drug products not rejected
    Drug products failing to meet established standards, specifications, and quality control criteria are not rejected.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 25, 2019
    Jan 25, 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.
  • Mar 6, 2017
    Mar 6, 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
    Scientifically sound laboratory controls
    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 1, 2015
    Sep 1, 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.
    3 citations
    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.
    Scientifically sound laboratory controls
    Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials conform to appropriate standards of identity, strength, quality and purity.
    Review of representative number of batches
    Written procedures are not followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 17, 2014
    Sep 17, 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.
    1 citation
    Computer control of master formula records
    Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 23, 2013
    Aug 23, 2013
    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 4, 2012
    Jan 4, 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.
  • Nov 5, 2010
    Nov 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 12, 2010
    Feb 12, 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.
    2 citations
    Written procedures fail to include
    Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for removal or obliteration of previous batch identification.
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 2, 2009
    Feb 2, 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.

Albuterol Sulfate

CompanyBryant Ranch Prepack
Dosage
108mcg
Aerosol, metered in a canister (200)
NDC: 72162-1212-2

Albuterol Sulfate

CompanyProficient Rx Lp
Dosage
108mcg
Aerosol, metered in a canister (200)
NDC: 82804-036-67

Albuterol Sulfate

CompanyQuality Care Products
Dosage
108mcg
Aerosol, metered in a canister (200)
NDC: 55700-908-67

Albuterol Sulfate

CompanyPreferred Pharmaceuticals
Dosage
108mcg
Aerosol, metered in a canister (200)
NDC: 68788-7996-2

Albuterol Sulfate

CompanySandoz
Dosage
108mcg
Aerosol, metered in a canister (200)
NDC: 0781-7296-85

Estradiol Transdermal System

CompanySandoz
Dosage
Estradiol
0.06mg/d
Patch in a patch (7d)
NDC: 0781-7134-X

Estradiol Transdermal System

CompanySandoz
Dosage
Estradiol
0.075mg/d
Patch in a patch (7d)
NDC: 0781-7136-X

Estradiol Transdermal System

CompanySandoz
Dosage
Estradiol
0.025mg/d
Patch in a patch (7d)
NDC: 0781-7119-X

Estradiol Transdermal System

CompanySandoz
Dosage
Estradiol
0.038mg/d
Patch in a patch (7d)
NDC: 0781-7122-X

Estradiol Transdermal System

CompanySandoz
Dosage
Estradiol
0.05mg/d
Patch in a patch (7d)
NDC: 0781-7133-X

Estradiol Transdermal System

CompanySandoz
Dosage
Estradiol
0.1mg/d
Patch in a patch (7d)
NDC: 0781-7104-X

Fentanyl System

CompanyAlvogen
Dosage
Fentanyl
100mcg
Patch in a pouch (1)
NDC: 47781-428-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].