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Genus Lifesciences Inc.

United States See location details
Last FDA Action: Jul 31, 2024

This drug manufacturing facility is registered with the FDA by Genus Lifesciences Inc.. ProPublica was able to identify at least 32 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.

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.

  • Jul 31, 2024
    Jul 31, 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.
  • Sep 20, 2019
    Sep 20, 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
    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.
    Investigations of discrepancies, failures
    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
    Contamination, chemical or physical change, deterioration
    An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Nov 28, 2018
    Nov 28, 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.
  • Jul 20, 2018
    Jul 20, 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.
    5 citations
    Component identity verification
    Drug product component testing is deficient in that at least one specific test to verify the identity of each component is not performed.
    Establish reliability of supplier's C of A
    Establishment of the reliability of the closure supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
    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.
  • Sep 29, 2017
    Sep 29, 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.
    2 citations
    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.
    Complete test data included in records
    Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 11, 2016
    Aug 11, 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.
  • Oct 17, 2014
    Oct 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Dec 5, 2012
    Dec 5, 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.
  • Dec 8, 2011
    Dec 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.
  • 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.
    5 citations
    Cleaning / Sanitizing / Maintenance
    Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
    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.
    Procedure Deviations Recorded and Justified
    Deviations from written production and process control procedures are not recorded and justified.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jul 7, 2009
    Jul 7, 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.
    4 citations
    Deviations of production time limits
    Deviations from production time limits are not justified.
    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.
    In-process and laboratory control results
    Batch production and control records do not include laboratory control results for each batch of drug product produced.
    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.

Chlorpromazine Hydrochloride

CompanySandoz
Dosage
100mg/mL
Concentrate in a bottle, plastic (240mL)
NDC: 0781-4028-22

Chlorpromazine Hydrochloride

CompanySandoz
Dosage
30mg/mL
Concentrate in a bottle, plastic (120mL)
NDC: 0781-4027-53

Cocaine Hydrochloride

CompanyGenus Lifesciences
Dosage
40mg/mL
Green solution in a bottle, glass (4mL)
NDC: 64950-362-04

Cocaine Hydrochloride

CompanyLxo Us
Dosage
40mg/mL
Green solution in a bottle, glass (4mL)
NDC: 70839-362-04

Hydrocodone Bitartrate And Acetaminophen

CompanyGenus Lifesciences
Dosage
Hydrocodone Bitartrate
7.5mg/15mL
Acetaminophen
325mg/15mL
Red tropical fruit punch-flavored solution in a bottle (473mL)
NDC: 64950-343-16

Hydrocodone Bitartrate And Homatropine Methylbromide

CompanyPai Holdings, Llc Dba Pai Pharma
Dosage
Hydrocodone Bitartrate
5mg/5mL
Homatropine Methylbromide
1.5mg/5mL
Red cherry-flavored solution in a cup, unit-dose (5mL)
NDC: 0121-1036-X

Hydrocodone Bitartrate And Homatropine Methylbromide

CompanyGenus Lifesciences
Dosage
Hydrocodone Bitartrate
5mg
Homatropine Methylbromide
1.5mg
White round tablet marked with 205
NDC: 64950-206-X

Hydrocodone Bitartrate And Homatropine Methylbromide

CompanyGenus Lifesciences
Dosage
Hydrocodone Bitartrate
5mg/5mL
Homatropine Methylbromide
1.5mg/5mL
Red cherry-flavored solution in a bottle (473mL)
NDC: 64950-371-47

Phenobarbital

CompanyTaro Pharmaceuticals U.s.a
Dosage
32.4mg
White round tablet marked with L H 5
NDC: 51672-5327-X

Phenobarbital

CompanyTaro Pharmaceuticals U.s.a
Dosage
15mg
White round tablet marked with L H 1
NDC: 51672-5331-X

Phenobarbital

CompanyGenus Lifesciences
Dosage
16.2mg
White round tablet marked with 2 LH
NDC: 64950-572-X

Phenobarbital

CompanyGenus Lifesciences
Dosage
30mg
White round tablet marked with 7 LH
NDC: 64950-573-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].