Skip to content
ProPublica Donate
ProPublica Donate
New Search

Pai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma

United States See location details
Last FDA Action: Aug 1, 2025

This drug manufacturing facility is registered with the FDA by Pai Holdings, Llc. ProPublica was able to identify at least 91 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
17 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.

7 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.

  • Aug 1, 2025
    Aug 1, 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.
  • Jan 28, 2025
    Jan 28, 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.
  • Aug 2, 2023
    Aug 2, 2023

    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.
  • Sep 15, 2021
    Sep 15, 2021
    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 6, 2020
    Feb 6, 2020
    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 22, 2019
    Feb 22, 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.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • May 15, 2018
    May 15, 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.
  • Jan 12, 2018
    Jan 12, 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 8, 2016
    Jul 8, 2016
    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 for non-sterile drug products
    Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 20, 2015
    Aug 20, 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.
  • Aug 20, 2015
    Aug 20, 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.
    2 citations
    Failure to develop written procedures
    Written procedures have not been developed for the receipt and reporting to FDA of post marketing adverse drug experiences.
    Late submission of 15-day report
    Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 22, 2014
    Jan 22, 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.
  • Sep 13, 2012
    Sep 13, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Sep 13, 2012
    Sep 13, 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.
  • Apr 6, 2011
    Apr 6, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Apr 6, 2011
    Apr 6, 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
    Buildings not maintained in good state of repair
    Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained in a good state of repair.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Aug 24, 2009
    Aug 24, 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.
    3 citations
    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.
    Components withheld from use pending release
    Each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
    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.
  • Aug 11, 2009
    Aug 11, 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.

Acetaminophen And Codeine Phosphate

CompanyPai Holdings, Llc Dba Pai Pharma
Dosage
Acetaminophen
300mg/12.5mL
Codeine Phosphate
30mg/12.5mL
Orange cherry-flavored solution in a cup, unit-dose (12.5mL)
NDC: 0121-1008-X

Acetaminophen And Codeine Phosphate

CompanyRedpharm Drug
Dosage
Acetaminophen
120mg/5mL
Codeine Phosphate
12mg/5mL
Orange cherry-flavored solution in a bottle (118mL)
NDC: 67296-0525-1

Acetaminophen And Codeine Phosphate

CompanyGenus Lifesciences
Dosage
Acetaminophen
120mg/5mL
Codeine Phosphate
12mg/5mL
Orange cherry-flavored solution in a bottle, plastic (118mL)
NDC: 64950-374-X

Acetaminophen And Codeine Phosphate

CompanyProficient Rx Lp
Dosage
Acetaminophen
120mg/5mL
Codeine Phosphate
12mg/5mL
Orange cherry-flavored solution in a bottle (118mL)
NDC: 63187-291-04

Amantadine Hydrochloride

CompanyPai Holdings, Llc Dba Pai Pharma
Dosage
50mg/5mL
Raspberry-flavored solution in a bottle (473mL)
NDC: 0121-0646-X

Amantadine Hydrochloride

CompanyCardinal Health 107
Dosage
50mg/5mL
Raspberry-flavored solution in a cup, unit-dose (10mL)
NDC: 55154-9444-5

Amantadine Hydrochloride

CompanyAmerican Health Packaging
Dosage
50mg/5mL
Raspberry-flavored solution in a cup, unit-dose (10mL)
NDC: 60687-797-X

Amantadine Hydrochloride

CompanyAtlantic Biologicals
Dosage
50mg/5mL
Raspberry-flavored solution in a cup, unit-dose (10mL)
NDC: 17856-0646-X

Atovaquone

CompanyPai Holdings, Llc Dba Pai Pharma
Dosage
750mg/5mL
Bright yellow tutti frutti-flavored suspension in a cup, unit-dose (5mL)
NDC: 0121-1016-X

Atovaquone

CompanyMckesson Corporation Dba Sky Packaging
Dosage
750mg/5mL
Bright yellow tutti frutti-flavored suspension in a cup, unit-dose (5mL)
NDC: 63739-203-X

Buprenorphine And Naloxone

CompanyPai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma
Dosage
Buprenorphine Hydrochloride
2mg
Naloxone Hydrochloride
0.5mg
White to off-white lemon flavor, lime flavor-flavored round tablet marked with N2 Up Arrow
NDC: 0121-1018-30

Buprenorphine And Naloxone

CompanyPai Holdings, Llc Dba Pharmaceutical Associates, Inc. And Dba Pai Pharma
Dosage
Buprenorphine Hydrochloride
8mg
Naloxone Hydrochloride
2mg
White to off-white lemon flavor, lime flavor-flavored round tablet marked with N8 Up Arrow
NDC: 0121-2036-30

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].