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.
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?
Which Drugs Are Included?
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.
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?
