FAQ
What is Rx Inspector?
The label on a pill bottle may list the distributor or repackager of the generic drug, but it does not necessarily indicate where it was actually manufactured. Without that critical information, there is no way to know if and when the plant was inspected for quality and safety violations and what the Food and Drug Administration found.
Now you can.
To bring more light to the world of drug manufacturing, ProPublica has connected the disparate databases and websites where the FDA disseminates this information. We also obtained documentation from thousands of FDA inspections of generic drug factories since 2008. At one point, it sued the FDA in federal court for plant locations and received a partial list.
Our database shows the facility where your prescription generic drug was manufactured and the inspection report from the FDA.
Data isn’t perfect. For example, one company may have acquired another company or moved manufacturing to another location, so the FDA information may be out of date. However, we believe this is an important first step in unraveling a process that authorities and drug companies have been trying to keep secret from consumers.
How does it work?
Enter the name of the generic prescription drug and the company name as it appears on the pill bottle or drug label. It then searches the database for possible matches. If there are multiple matches, you can narrow your search using the markings on the pill and other filter options. If the package has a national drug code, you can also use that.
Clicking on a drug will display the manufacturing facilities that were able to connect to that drug. Click on a facility to see its location, other drugs it manufactures, and FDA testing information.
What is ProPublica?
ProPublica is an independent, nonprofit news company that produces investigative reporting in the public interest. As part of our “Rx Roulette” series, we’ve been investigating the FDA’s oversight of generic drugs. The country’s health care system has come to rely on generic drugs, which are often cheaper than brand-name products, to ensure patients have access to affordable medicines. Generic drugs currently account for approximately 90% of prescription drugs dispensed in the United States. It was discovered that authorities had secretly allowed some noncompliant overseas factories to continue shipping medicines to the United States after the facilities were officially banned from the U.S. market for violations so serious. When the FDA accepted drugs from these factories, the FDA did not regularly test them to ensure they did not put patients at risk. When ProPublica hired a laboratory to test samples of a critical generic drug for organ transplant patients, we discovered quality concerns that could compromise its effectiveness. It also found that the FDA preemptively excluded drug names from inspection reports on foreign facilities, prompting careful interpretation of laws that require governments to protect trade secrets and confidential information.
What drugs are included?
Our ongoing reporting has focused on the safety of generic drugs, which account for the majority of all prescriptions filled in the United States. Therefore, this tool does not include branded or over-the-counter drugs. We also excluded gases (such as oxygen tanks) and intradermal route drugs (many of these were allergy tests for things like cat hair). We also included biologics such as insulin. We chose to include authorized generics, which are branded drugs sold without a brand name label, because we believed that consumers may not know that their “generics” are actually branded drugs.
What do the test results mean?
The possible FDA compliance outcomes we highlight are:
Import alert. This is rare and means that medicines from this facility are prohibited from entering the United States. Specifically, it includes warnings regarding FDA drug manufacturing practices. The agency sometimes exempts certain drugs from import bans, ostensibly to prevent drug shortages. Warning letter. This is a disciplinary tool used by FDA to uncover serious violations of federal requirements. The company has the opportunity to provide a response and/or plan to correct the issue. The agency may later issue a “termination letter” confirming that the issues raised in the previous warning letter have been corrected. But that doesn’t always happen. Unacceptable compliance condition. This means that inspectors found significant problems with the facility and the agency ultimately recommended formal compliance action. In such cases, the FDA typically suspends the facility’s pending drug approvals. The agency classifies this as “formal measures indicated.” Several problems were found, but the FDA took no further action. This is very common. This means that the FDA has found a problem but has determined that the facility can voluntarily correct the problem. In some cases, inspectors may have recommended a different (potentially more serious) classification, but authorities declined to seek further enforcement at the time. The agency classifies this as an “instruction for voluntary action.” The inspector has documented the problem. Inspectors can use the 483 form to file notes summarizing deficiencies observed during the inspection. In some cases, Form 483 may not be tied to an FDA inspection designation, but indicates that the inspector submitted this form as part of an inspection that is probably not included on the public inspection dashboard. acceptable condition. This is common and the best possible outcome of the test. This means the FDA took no compliance action and ProPublica found no problems documented by inspectors. That doesn’t necessarily mean the problem won’t occur. Inspectors may report concerns to site management that they feel do not need to be documented on a 483. The authorities classify this as “no action indicated”.
There may be additional communications, such as issues that are being resolved, that are not published and therefore not reflected in our database.
What should I do if I find something of concern?
ProPublica does not provide medical advice. Keep in mind that if you find a questionable test report, it doesn’t necessarily mean your medicine is at risk. Your doctor or pharmacist will advise you not to stop taking your medicine. Instead, you should discuss your concerns with your health care provider.
There are often different manufacturers of the same generic drug, and your availability will depend on the pharmacy you shop at and its inventory. If you change the pharmacy where you write your prescription, you may be able to obtain a generic drug made by a different manufacturer.
The FDA maintains a database known as the FDA Adverse Event Reporting System, which tracks reports of potential drug quality problems and sudden and unexpected consumer health conditions. Both medical professionals and consumers can report issues.
How did ProPublica piece together this information?
Structured product label database. National Drug Code Directory. Electronic drug registration and listing system. Data from the agency’s inspection dashboard. Spreadsheet of addresses of facilities that sued the FDA. Associated with drug application number. Form 483 documents received from Freedom of Information Act requests.
ProPublica briefed the FDA on the app and the methods used to build it, but the FDA did not comment. The agency previously told ProPublica that inspection reports do not reveal where the drugs are manufactured to protect what it considers commercially sensitive information.
How do I report incorrect information?
If you work for a manufacturer or notice that the information we are displaying may be incorrect, please contact us by email. [email protected].
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