ProPublica
Donate
New Search

Invagen Pharmaceuticals, Inc

United States See location details
Last FDA Action: Oct 25, 2023

This drug manufacturing facility is registered with the FDA by Invagen Pharmaceuticals, Inc. ProPublica was able to identify at least 377 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
16 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.

13 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.

  • Oct 25, 2023
    Oct 25, 2023
    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.
  • Dec 6, 2019
    Dec 6, 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.
    3 citations
    Written in-process control procedures
    Written procedures are not established that describe the in-process controls and tests to be conducted on appropriate samples of in-process materials of each batch.
    Testing and release for distribution
    Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
    Batch production and Batch Control Record Requirements
    The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • May 25, 2018
    May 25, 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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    6 citations
    Backup file not maintained
    Failure to maintain a backup file of data entered into the computer or related system.
    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.
    Written program not followed
    The written stability testing program is not followed.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Mar 30, 2017
    Mar 30, 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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Apr 20, 2016
    Apr 20, 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.
  • May 26, 2015
    May 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.
    1 citation
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 13, 2015
    Mar 13, 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 8, 2013
    Mar 8, 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.
    3 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    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.
    Valid stability test methods
    The written stability program for drug products does not include reliable, meaningful, and specific test methods.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jun 14, 2012
    Jun 14, 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
    Handling and Storage to Prevent Contamination
    There was a failure to handle and store components at all times in a manner to prevent contamination.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 2, 2012
    Mar 2, 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.
    2 citations
    Procedures for non-sterile drug products
    Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
    Investigations of discrepancies, failures
    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 12, 2011
    Aug 12, 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.
  • Apr 13, 2011
    Apr 13, 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.
    4 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    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.
    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.
  • Nov 10, 2010
    Nov 10, 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.
    8 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    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.
    Reprocessing procedures not written or followed
    Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with all established standards, specifications, and characteristics are not written.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 27, 2010
    Aug 27, 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.
    3 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Written record of investigation incomplete
    Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
    Failure to meet specifications
    An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning a failure of one or more distributed batches of a drug to meet the specifications established for it in the application.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 19, 2010
    Feb 19, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 12, 2009
    May 12, 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.
    6 citations
    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.
    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.
    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.

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.

Alfuzosin Hydrochloride

CompanyAphena Pharma Solutions - Tennessee
Dosage
10mg
Off-white round tablet, extended release marked with IG 302
NDC: 43353-945-X

Alfuzosin Hydrochloride

CompanyExelan Pharmaceuticals
Dosage
10mg
Off-white round tablet, extended release marked with IG 302
NDC: 76282-302-X

Alfuzosin Hydrochloride Extended Release

CompanyCipla Usa
Dosage
Alfuzosin Hydrochloride
10mg
Off-white round tablet marked with IG 302
NDC: 69097-844-X

Amlodipine Besylate

CompanyAphena Pharma Solutions - Tennessee
Dosage
10mg
White round tablet marked with 239 IG
NDC: 43353-989-X

Amlodipine Besylate

CompanyExelan Pharmaceuticals
Dosage
10mg
White round tablet marked with T 102
NDC: 76282-509-X

Amlodipine Besylate

CompanyCipla Usa
Dosage
2.5mg
White round tablet marked with 237 IG
NDC: 69097-836-X

Amlodipine Besylate

CompanyCipla Usa
Dosage
10mg
White round tablet marked with 239 IG
NDC: 69097-838-X

Amlodipine Besylate

CompanyBryant Ranch Prepack
Dosage
2.5mg
White round tablet marked with 237 IG
NDC: 63629-1023-X

Amlodipine Besylate

CompanyBryant Ranch Prepack
Dosage
2.5mg
White round tablet marked with 237 IG
NDC: 71335-0833-X

Amlodipine Besylate

CompanyExelan Pharmaceuticals
Dosage
5mg
White round tablet marked with 238 IG
NDC: 76282-238-X

Amlodipine Besylate

CompanyExelan Pharmaceuticals
Dosage
2.5mg
White round tablet marked with T 143
NDC: 76282-507-X

Amlodipine Besylate

CompanyExelan Pharmaceuticals
Dosage
5mg
White round tablet marked with T 144
NDC: 76282-508-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].