How the FDA record score is counted
The FDA record score is one number from 0 to 100 for a single site, identified by its FDA Establishment Identifier (FEI). It counts the adverse public FDA records for that FEI and weights each one by its age. It is a count, not a rating: it does not say whether a site is good or bad, and a low number does not establish that a site is safe.
Every point comes from a record listed under the number on the site's page, with its date and the points it adds, so you can check the count yourself.
Points per record
| Record for the FEI | Points |
|---|---|
| Inspection classified OAI (Official Action Indicated) | 30 |
| Warning letter with no close-out letter listed | 30 |
| Warning letter that FDA closed out | 15 |
| Class I recall with the FEI as the recalling firm | 15 |
| Inspection classified VAI (Voluntary Action Indicated), the 3 most recent only | 6 |
| Class II recall with the FEI as the recalling firm | 4 |
| Import refusals: for every 10 in one calendar year | 2, up to 10 for the year |
Inspections classified NAI (No Action Indicated) add nothing. Class III recalls and recalls FDA has not yet classified add nothing.
Age weight
| Age of the record | Weight |
|---|---|
| Under 2 years | 1 |
| 2 to under 5 years | 0.6 |
| 5 to under 10 years | 0.25 |
| 10 years or older, or no date listed | 0 |
Each record adds its points multiplied by its weight. The results are summed and the score stops at 100. Import refusals in a past year are aged from the last day of that year.
Not scored
A site with no inspection in FDA's published inspection data is shown as "Not scored", never as 0. A 0 means the site has been inspected and the points for its records add up to 0. A site with a 0 can still have records that add nothing, such as a record 10 years or older, a record with no date, or a VAI inspection beyond the 3 most recent. Those records are listed on the site's page with 0 points.
Limits
- FDA publishes inspection classifications after a delay, often several months, so a recent inspection can be missing.
- FDA's published inspection data is not a complete list of every inspection.
- Warning letters are counted when FDA's Data Dashboard lists them for the FEI, or when the letter's own text states the FEI. A letter that does neither is not counted. A dashboard entry is linked to FDA's letter page by FDA's case number, which is how its close-out is known. Failing that, a letter and a dashboard entry dated within 45 days of each other are counted as one letter.
- Recalls are counted for the FEI FDA's Enforcement Report names as the recalling firm, which is not always the site that made the product.
- Import alerts are not counted. FDA's import alert lists name firms without an FEI, so a site cannot be matched to one reliably.
- FDA's Data Dashboard does not show whether a warning letter was closed out. A dashboard entry that cannot be linked to a letter page is counted as not closed out and is labelled that way.
- Sites that FDA inspects more often have more chances to collect points. Only the 3 most recent VAI inspections add points, which limits this but does not remove it.
- The score is for one site. It is not rolled up to a parent company.
Report a wrong match
If a record listed for a site belongs to a different site, write to hello@regdatalab.com with the FEI and the record. RegDataLab is independent of the FDA.