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Gmp Laboratories Of America, Inc.

United States See location details

This drug manufacturing facility is registered with the FDA by Gmp Laboratories Of America Inc..

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
5 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.

  • Dec 16, 2024
    Dec 16, 2024
    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.
    4 citations
    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.
    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.
    SOPs not followed / documented
    Written production and process control procedures are not followed in the execution of production and process control functions.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Jan 14, 2020
    Jan 14, 2020
    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.
    5 citations
    Procedures not in writing, fully followed
    The responsibilities and procedures applicable to the quality control unit are not in writing.
    Quarantined Drug Products Area
    Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to the quarantine storage of drug products prior to release.
    Equipment construction - reactive surfaces
    Equipment surfaces that contact components, in-process materials, and drug products are reactive, additive or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.
    View Inspector Notes
    Inspector’s notes summarizing deficiencies observed during an inspection.
  • Sep 25, 2013
    Sep 25, 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.
    9 citations
    Physical plant - separate areas - holding
    You did not use separate or defined areas of adequate size or other control systems prevent contamination or mix-ups of components or dietary supplements during holding operations.
    Physical plant - design and construction
    Your physical plant was not designed and constructed in a manner that prevents contamination of components, dietary supplements, or contact surfaces.
    Quality control - quality, dietary supplement
    You did not implement quality control operations to ensure the quality of the dietary supplement.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Mar 29, 2012
    Mar 29, 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.
    11 citations
    Hand-washing facilities
    Your hand-washing facilities are not convenient.
    Hold - temperature, humidity, light
    You did not hold dietary supplements under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected.
    Written procedures - product complaint
    You did not follow written procedures for the requirements to review and investigate a product complaint.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.
  • Jan 20, 2010
    Jan 20, 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.
    17 citations
    Water supply - not component - suitability
    Water that does not become a component of the dietary supplement was not at suitable temperature for all uses.
    Plumbing - backflow, cross connection
    The plumbing in your physical plant allows backflow from piping systems that discharge waste water or sewage and piping systems that carry water used for manufacturing dietary supplements, for cleaning contact surfaces, or for use in bathrooms or hand-washing facilities.
    Equipment - maintain, clean, sanitize
    You did not maintain, clean, and sanitize equipment and utensils used to manufacture, package, label, or hold components or dietary supplements.
    ProPublica was unable to locate a 483 form detailing issues found in this inspection.

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].