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West-ward Columbus Inc.

United States See location details
Last FDA Action: Jan 17, 2025

This drug manufacturing facility is registered with the FDA by West-ward Columbus Inc.. ProPublica was able to identify at least 287 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
24 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.

3 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.

  • Jan 17, 2025
    Jan 17, 2025
    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 15, 2022
    Sep 15, 2022
    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.
  • Nov 22, 2019
    Nov 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.
  • Apr 16, 2019
    Apr 16, 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.
  • Apr 18, 2018
    Apr 18, 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
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Label storage access limited to authorized personnel
    Access to the storage area for labels and labeling materials is not limited to authorized personnel.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 19, 2017
    Sep 19, 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.
  • Aug 29, 2017
    Aug 29, 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.
  • May 18, 2017
    May 18, 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.
  • Apr 14, 2017
    Apr 14, 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.
  • Jul 28, 2016
    Jul 28, 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.
  • Aug 14, 2015
    Aug 14, 2015
    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

    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, 2014
    Jun 26, 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.
    2 citations
    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.
    Summary
    An annual report did not include a brief summary of significant new information from the previous year that might affect the safety, effectiveness, or labeling of the drug product.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 21, 2014
    May 21, 2014
    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 20, 2013
    Dec 20, 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.
  • Apr 24, 2013
    Apr 24, 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.
  • Nov 30, 2012
    Nov 30, 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.
  • Oct 11, 2012
    Oct 11, 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.
  • Jun 29, 2012
    Jun 29, 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.
  • Mar 7, 2012
    Mar 7, 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.
  • Oct 21, 2011
    Oct 21, 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.
  • Jan 20, 2011
    Jan 20, 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.
    1 citation
    Training , Education , Experience overall
    Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Feb 24, 2010
    Feb 24, 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.
  • May 6, 2009
    May 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.

Acarbose

CompanyHikma Pharmaceuticals Usa
Dosage
25mg
White round tablet marked with 54 311
NDC: 0054-0140-25

Acarbose

CompanyHikma Pharmaceuticals Usa
Dosage
100mg
White round tablet marked with 54 251
NDC: 0054-0142-25

Acarbose

CompanyPd-rx Pharmaceuticals
Dosage
50mg
White round tablet marked with 54 737
NDC: 72789-132-X

Acarbose

CompanyPd-rx Pharmaceuticals
Dosage
100mg
White round tablet marked with 54 251
NDC: 72789-133-X

Acarbose

CompanyHikma Pharmaceuticals Usa
Dosage
50mg
White round tablet marked with 54 737
NDC: 0054-0141-X

Acarbose

CompanyPd-rx Pharmaceuticals
Dosage
25mg
White round tablet marked with 54 311
NDC: 72789-131-X

Alendronate Sodium

CompanyHikma Pharmaceuticals Usa
Dosage
70mg/75mL
Colorless to pale pink raspberry-flavored solution in a bottle, unit-dose (75mL)
NDC: 0054-0282-59

Alprazolam

CompanyHikma Pharmaceuticals Usa
Dosage
1mg/mL
Solution, concentrate in a bottle (30mL)
NDC: 0054-3068-44

Alvimopan

CompanyGolden State Medical Supply
Dosage
12mg
Blue capsule marked with 54 88
NDC: 51407-870-33

Alvimopan

CompanyHikma Pharmaceuticals Usa
Dosage
12mg
Blue capsule marked with 54 88
NDC: 0054-0668-82

Balsalazide Disodium

CompanyHikma Pharmaceuticals Usa
Dosage
750mg
Orange capsule marked with 54 795
NDC: 0054-0079-28

Balsalazide Disodium

CompanyPd-rx Pharmaceuticals
Dosage
750mg
Orange capsule marked with 54 795
NDC: 72789-149-69

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].