Questions fréquemment posées

What Is Rx Inspector?

Labels on pill bottles may list the distributor or repackager of a generic drug, but they don’t always show where it was really made. Without that critical information, you can’t learn what the Food and Drug Administration discovered if and when that factory was inspected for quality and safety violations.

Now you can.

To bring more sunlight to the world of drug manufacturing, ProPublica connected the disparate databases and websites where the FDA scatters this information. We also obtained documents stemming from thousands of FDA inspections of generic drug factories since 2008. At one point, we sued the FDA in federal court for factory locations and received a partial list.

Our database will show you the facility that manufactured your prescription generic drugs and any inspection reports we have from the FDA.

The data is not perfect: It is possible the FDA’s information is not up-to-date because, for example, one company acquired another or moved its manufacturing to a different location. However, we believe this is an important first step in shedding light on a process that the agency and drugmakers have sought to keep secret from consumers.

You enter in the name of your generic prescription drug, as well as the company name found on your pill bottle or drug label. We then search through our database for potential matches. If there are multiple matches, you can narrow your search using the markings found on a pill or other filtering options. If you have a National Drug Code on the package, you can use that as well.

When you click on the drug, we will show you any manufacturing facilities we have been able to connect to it. Clicking on a facility will let you see information on where the facility is located, what other drugs it makes and any FDA inspection information.

ProPublica is an independent, nonprofit newsroom that produces investigative journalism in the public interest. As part of our “Rx Roulette” series, we have been investigating the FDA’s oversight of generic drugs. The nation’s health care system has come to rely on generics — which are often cheaper than their brand-name counterparts — to ensure patients have reliable access to affordable medications. Generics now make up about 90% of the prescription drugs dispensed in the U.S.
We’ve found that the agency quietly allowed some substandard foreign factories to continue shipping medication to the United States after flagging violations so severe that the facilities were officially banned from the U.S. market. When the FDA let drugs from those factories in, the agency did not regularly test them to ensure they would not put patients at risk.
When ProPublica hired a lab to test samples of an important generic for organ transplant patients, we found quality concerns that could compromise their effectiveness. We also found that the FDA preemptively blocks out drug names on inspection reports about foreign facilities, invoking a cautious interpretation of a law that requires the government to protect trade secrets and confidential information.

Our ongoing reporting has focused on the safety of generic drugs, which represent the vast majority of all prescriptions filled in the United States. Thus, the tool does not include brand-name or over-the-counter drugs. Further, we excluded gases (like oxygen tanks) and intradermal route drugs (many of these were allergy tests for things like feline hair). We included biological drug products, such as insulin. We opted to include authorized generics, which are brand-name drugs that are marketed without the brand-name label, because we thought consumers may not know their “generic” is actually a brand-name drug.

Que signifient les résultats de l’inspection ?

These are the possible FDA compliance outcomes we highlight:

Avertissement d’importation. Il s'agit d'un événement rare et cela signifie que l'importation de médicaments de cet établissement vers les États-Unis est interdite. Nous incluons spécifiquement des avertissements concernant les normes de fabrication de médicaments de la FDA. L'autorité exempte parfois certains médicaments des interdictions d'importation, apparemment pour éviter des pénuries de médicaments.

  • Lettre d'avertissement. Il s'agit d'un outil disciplinaire utilisé par la FDA pour découvrir des violations importantes des réglementations fédérales. La Société a la possibilité de répondre et/ou de présenter ses plans pour résoudre les problèmes. L'agence pourrait ultérieurement émettre une « lettre d'achèvement » indiquant qu'elle a confirmé que les problèmes soulevés dans une précédente lettre d'avertissement ont été résolus. Mais cela n'arrive pas toujours.
  • Statut de conformité inacceptable. Cela signifie que les inspecteurs ont découvert de graves problèmes dans l'installation et que l'agence a finalement recommandé des mesures officielles de conformité. Dans de tels cas, la FDA suspend généralement les approbations de médicaments en attente de l'établissement. L'autorité qualifie cela de « mesure administrative indiquée ».
  • Certains problèmes ont été identifiés, mais aucune autre action de la part de la FDA. Cela arrive très souvent. Cela signifie que la FDA a détecté des problèmes mais a décidé que l'établissement pouvait les résoudre volontairement. Dans certains cas, les inspecteurs peuvent avoir recommandé une classification différente (potentiellement plus grave), mais l'agence a alors refusé de poursuivre l'application de la loi. L’autorité qualifie cela d’« action volontaire indiquée ».
  • L'inspecteur a documenté les problèmes. Les inspecteurs peuvent utiliser un formulaire 483 pour soumettre des notes résumant les lacunes constatées lors d'une inspection. Dans certains cas, nous ne pouvons pas associer un formulaire 483 à une désignation d'inspection de la FDA, mais nous montrerons qu'un inspecteur a soumis ce formulaire, éventuellement dans le cadre d'une inspection qui n'était pas incluse dans le tableau de bord d'inspection public.
  • État acceptable. Ceci est courant et constitue le meilleur résultat possible d’une inspection. Cela signifie que la FDA n'a pris aucune mesure de conformité et que ProPublica n'a trouvé aucun problème documenté par les inspecteurs. Cela ne signifie pas toujours qu’il n’y a pas eu de problèmes. Parfois, les inspecteurs discutent avec la direction sur place de préoccupations qui, selon eux, n'ont pas besoin d'être documentées dans un document 483. L’autorité qualifie cela de « aucune mesure indiquée ».

    • Il peut y avoir des communications supplémentaires, y compris des problèmes résolus, qui ne sont pas incluses dans notre base de données car elles n'ont pas été publiées.

    Que se passe-t-il si je trouve quelque chose d'inquiétant ?

    ProPublica does not provide medical advice. Keep in mind that if you turn up a troubling inspection report, it doesn’t necessarily mean that your drug is compromised. Doctors and pharmacists advise that you not stop taking your medications. Instead, you should talk to your health care provider about any concerns.

    There are often different manufacturers of the same generic drug, and which manufacturer you get can depend on the pharmacy where you shop and what it has in stock. Changing the pharmacy where you fill your prescription might mean you can get a generic made by a different manufacturer.

    The FDA maintains a database known as the FDA Adverse Event Reporting System that tracks reports about potential drug-quality problems and sudden and unexpected health conditions among consumers. Both health care professionals and consumers can report problems.

    • 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.

    If you work for a manufacturer or otherwise see that information we are displaying may be incorrect, please email [email protected].

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