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Sandoz Inc

United States See location details
Last FDA Action: Apr 16, 2019

This drug manufacturing facility is registered with the FDA by Sandoz Inc. ProPublica was able to identify at least 65 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
8 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.

  • Apr 16, 2019
    Apr 16, 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
    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.
    Lab controls established, including changes
    The establishment of specifications and test procedures including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
    Investigations of discrepancies, failures
    There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Mar 29, 2017
    Mar 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.
  • Oct 30, 2015
    Oct 30, 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.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Oct 17, 2013
    Oct 17, 2013
    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
    Written procedures fail to include
    Written procedures for cleaning and maintenance fail to include maintenance and cleaning schedules, description in sufficient detail of methods, equipment and materials used, description in sufficient detail of the methods of disassembling and reassembling equipment as necessary to assure proper cleaning and maintenance, and instructions for removal or obliteration of previous batch identification.
    Written record of investigation incomplete
    Written records of investigations into the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
    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.
  • Aug 14, 2012
    Aug 14, 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.
  • May 6, 2011
    May 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.
    11 citations
    Authority lacking to review records, investigate errors
    The quality control unit lacks authority to fully investigate errors that have occurred.
    Sanitation--buildings not clean, free of infestation
    Buildings used in the manufacture, processing, packing or holding of drug products are not free of infestation by rodents, birds insects, and other vermin.
    Equipment Design, Size and Location
    Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design, of adequate size, and suitably located to facilitate operations for its intended use.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • May 28, 2010
    May 28, 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.
  • Oct 8, 2008
    Oct 8, 2008
    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
    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.

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.

Alprazolam

CompanyA-s Medication Solutions
Dosage
1mg
Blue oval tablet marked with GG258
NDC: 50090-2896-X

Alprazolam

CompanyAdvanced Rx Pharmacy Of Tennessee
Dosage
1mg
Blue oval tablet marked with GG258
NDC: 80425-0100-X

Alprazolam

CompanyRemedyrepack
Dosage
1mg
Blue oval tablet marked with GG258
NDC: 70518-4137-0

Alprazolam

CompanyAphena Pharma Solutions - Tennessee
Dosage
0.5mg
Orange (peach) oval tablet marked with GG257
NDC: 71610-734-X

Alprazolam

CompanySandoz
Dosage
0.25mg
White oval tablet marked with GG256
NDC: 0781-1061-X

Alprazolam

CompanySandoz
Dosage
1mg
Blue oval tablet marked with GG258
NDC: 0781-1079-X

Alprazolam

CompanyProficient Rx Lp
Dosage
1mg
Blue oval tablet marked with GG258
NDC: 63187-443-X

Alprazolam

CompanyProficient Rx Lp
Dosage
2mg
White rectangle tablet marked with GG249
NDC: 63187-444-X

Alprazolam

CompanyA-s Medication Solutions
Dosage
0.25mg
White oval tablet marked with GG256
NDC: 50090-1864-X

Alprazolam

CompanyA-s Medication Solutions
Dosage
2mg
White rectangle tablet marked with GG249
NDC: 50090-2819-1

Alprazolam

CompanyAdvanced Rx Of Tennessee
Dosage
0.5mg
Orange ((peach)) oval tablet marked with GG257
NDC: 80425-0284-X

Alprazolam

CompanyPd-rx Pharmaceuticals
Dosage
2mg
White rectangle tablet marked with GG249
NDC: 55289-523-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].