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Exela Pharma Sciences, Llc.

United States See location details
Last FDA Action: Jul 2, 2025
Recent Compliance Action Read more

This drug manufacturing facility is registered with the FDA by Exela Pharma Sciences. ProPublica was able to identify at least 13 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.

5 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 2, 2025
    Jul 2, 2025
    Warning Letter

    The FDA issued a warning letter laying out significant issues.

    The letter is a disciplinary tool the FDA uses to lay out significant violations of manufacturing standards and to outline needed improvements. It often includes a summary of the steps the company had initially pledged to take to correct issues identified during inspections. There may be additional communications, including about issues being resolved, that are not reflected in our database because they have not been made public.
    View Warning Letter
  • Nov 15, 2024
    Nov 15, 2024

    An inspector documented issues at the facility.

    We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Jul 18, 2019
    Jul 18, 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.
    7 citations
    Environmental Monitoring System
    Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
    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.
    Containers & Closures Clean, Sterilized, Pyrogen-free
    Drug product closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 29, 2019
    Mar 29, 2019

    An inspector documented issues at the facility.

    We were unable to connect this 483 form to an FDA inspection designation, but we do know that an inspector filed this form observing problem(s).
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Dec 19, 2018
    Dec 19, 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.
  • Sep 11, 2018
    Sep 11, 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.
  • Sep 28, 2017
    Sep 28, 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.
    6 citations
    Environmental Monitoring System
    Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
    Calibration/Inspection/Checking not done
    Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
    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.
  • Jun 8, 2016
    Jun 8, 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.
  • Nov 21, 2014
    Nov 21, 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.
  • Aug 28, 2014
    Aug 28, 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.
  • Apr 12, 2013
    Apr 12, 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 20, 2012
    Jan 20, 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.
  • Sep 2, 2011
    Sep 2, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Dec 10, 2010
    Dec 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.
    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.

Caffeine Citrate

CompanyExela Pharma Sciences
Dosage
20mg/mL
Solution in a vial (3mL)
NDC: 51754-0501-X

Caffeine Citrate

CompanyExela Pharma Sciences
Dosage
20mg/mL
Injection in a vial (3mL)
NDC: 51754-0500-1

Cupric Chloride

CompanyExela Pharma Sciences
Dosage
0.4mg/mL
Injection, solution in a vial, single-dose (10mL)
NDC: 51754-0103-X

Potassium Acetate

CompanyExela Pharma Sciences
Dosage
200meq/100mL
Injection in a vial, glass (100mL)
NDC: 51754-2004-4

Potassium Acetate

CompanyExela Pharma Sciences
Dosage
3.93g/20mL
Injection, solution, concentrate in a vial, single-dose (20mL)
NDC: 51754-2001-4

Sodium Bicarbonate

CompanyA-s Medication Solutions
Dosage
84mg/mL
Injection, solution in a vial (50mL)
NDC: 50090-6813-0

Sodium Bicarbonate

CompanyCivica
Dosage
84mg/mL
Injection, solution in a vial (50mL)
NDC: 72572-740-X

Sodium Bicarbonate

CompanyExela Pharma Sciences
Dosage
84mg/mL
Injection, solution in a vial (50mL)
NDC: 51754-5001-X

Sodium Bicarbonate

CompanyExela Pharma Sciences
Dosage
84mg/mL
Injection, solution in a vial (10mL)
NDC: 51754-5011-4

Sodium Bicarbonate

CompanyExela Pharma Sciences
Dosage
75mg/mL
Injection, solution in a vial (50mL)
NDC: 51754-5002-5

Sodium Bicarbonate

CompanyMedical Purchasing Solutions
Dosage
84mg/mL
Injection, solution in a vial (50mL)
NDC: 71872-7310-1

Sodium Bicarbonate

CompanyExela Pharma Sciences
Dosage
42mg/mL
Injection, solution in a vial (10mL)
NDC: 51754-5012-4

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].