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Epic Pharma, Llc

United States See location details
Last FDA Action: Dec 7, 2023

This drug manufacturing facility is registered with the FDA by Epic Pharma, Llc. ProPublica was able to identify at least 203 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
12 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.

  • Dec 7, 2023
    Dec 7, 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.
  • Oct 23, 2023
    Oct 23, 2023
    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.
    1 citation
    Cleaning SOPs/instructions
    Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Feb 1, 2019
    Feb 1, 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.
    6 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.
    Calibration/Inspection/Checking not done
    Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
    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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Nov 6, 2018
    Nov 6, 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.
    1 citation
    Failure to develop written procedures
    Written procedures have not been developed for the receipt and reporting to FDA of post marketing adverse drug experiences.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 21, 2017
    Apr 21, 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
    Calibration/Inspection/Checking not done
    Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance.
    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.
  • Jun 4, 2015
    Jun 4, 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.
    5 citations
    Reports of Analysis (Components)
    Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
    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.
  • Dec 23, 2013
    Dec 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.
  • Nov 1, 2012
    Nov 1, 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 13, 2011
    Oct 13, 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.
  • Nov 16, 2010
    Nov 16, 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.
    4 citations
    Training , Education , Experience overall
    Employees engaged in the manufacture of a drug product lack the training required to perform their assigned functions.
    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.
    Annual visual exams of drug products
    Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 5, 2010
    Mar 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.
  • Nov 14, 2008
    Nov 14, 2008
    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.

Amphetamine Sulfate

CompanyEpic Pharma
Dosage
5mg
White (to off whitw) round tablet marked with 5 E29
NDC: 42806-029-01

Amphetamine Sulfate

CompanyEpic Pharma
Dosage
10mg
Blue (biconvex) round tablet marked with 10 E30
NDC: 42806-030-01

Azithromycin

CompanyDirectrx
Dosage
Azithromycin Monohydrate
200mg/5mL
(off-white), (pinkish) (banana-cherry), (banana-cherry)-flavored powder, for suspension in a bottle (22.5mL)
NDC: 72189-314-22

Azithromycin

CompanyNucare Pharmaceuticals
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle (15mL)
NDC: 68071-4773-5

Azithromycin

CompanyA-s Medication Solutions
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (15mL)
NDC: 50090-6296-0

Azithromycin

CompanyEpic Pharma
Dosage
Azithromycin Monohydrate
100mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (15mL)
NDC: 42806-147-31

Azithromycin

CompanyEpic Pharma
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (22.5mL)
NDC: 42806-150-33

Azithromycin

CompanyPuracap Laboratories Llc Dba Blu Pharmaceuticals
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (15mL)
NDC: 24658-706-32

Azithromycin

CompanyPreferred Pharmaceuticals
Dosage
Azithromycin Monohydrate
100mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (15mL)
NDC: 68788-7636-1

Azithromycin

CompanyPreferred Pharmaceuticals
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (30mL)
NDC: 68788-7549-3

Azithromycin

CompanyNucare Pharmaceuticals
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a box (30mL)
NDC: 68071-4795-3

Azithromycin

CompanyA-s Medication Solutions
Dosage
Azithromycin Monohydrate
200mg/5mL
Off-white, pinkish banana-cherry, banana-cherry-flavored powder, for suspension in a bottle, plastic (22.5mL)
NDC: 50090-6226-0

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].