Regulatory Reporting Service

HomeEvery FDA-regulated firm should be aware of its FDA inspection record.  Was your last inspection classified by your District as a potential Warning Letter target? Has FDA inspected your contract manufacturers in past fiscal years and found problems? What were the inspector’s findings, and the final inspection outcome?  Was a 483 issued?  Or, have you been making disease claims that have been the subject of an inspection under “Unapproved and Misbranded Drugs” without your knowledge?†

Now you can search available FDA data on recalls, Warning Letters, inspections, citations found on 483s, and tainted products* all in one place. This AUTOMATED SERVICE can supply a single (or multiple‡) report for the firm(s) of your choice, in both pdf and web-accessible formats.  The price for this service is $19.99 per firm, payable with PayPal or any credit card.  An example report is available (See why Raw Deal is my example.)

‡Note that the same firm may appear under several names or alternative spellings in FDA’s data.  I will attempt to find all instances and allow you to combine them on a single report at a price reduction, but sometimes this is not possible due to FDA data limitations.

† DISCLAIMER: When a firm is subject to further regulatory action, information may be redacted or completely absent.  Absence of an FDA record or specific citations and inspections should not be taken as evidence that the firm is compliant with all applicable regulations.

* Tainted products:  defined by FDA as potentially hazardous products with hidden ingredients (such as prescription drugs)