Where Was My Generic Prescription Drug Made? – Rx Inspector

Frequently Asked Questions

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.

How Does It Work?

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.

What Is ProPublica?

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.

Which Drugs Are Included?

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.

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.

What if I Find Something Concerning?

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.

How Did ProPublica Connect This Information?

• 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].