NEW Regulatory Action Reports Now Available Online

Regulatory Action Reports (click link for an example) are now available for individual firms as an automated service on my website.

Reports include data on recalls, Warning Letters, inspections, Form 483 observations and tainted products (products that are sold as dietary supplements but may contain one or more prescription drugs).  They include charts showing classes of recalls, score of actual inspection outcomes vs. typical inspection outcomes, and inspection citations and classifications if released by FDA1.

The data are culled from various FDA databases and OpenFDA and updated regularly as new data are issued by FDA.  Access the query form at:

Cost for a report on one firm starts at $19.99.  In some cases, you will be able to combine multiple firms or firm names on a single report at a discount rate. I accept PayPal, and all major credit cards via PayPal (you do not need a PayPal account)

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Queries for Recalls and SAERs from data posted by OpenFDA are still free!

1  If FDA regulatory action is pending, or FDA has not yet inspected a firm, there may be no data available in my database. You will get a preliminary assessment of available data on the firm before you pay for the report.