OpenFDA: CAERs | Recalls | Regulatory Action Reports |
This chart shows the top 10 observations (for a 21 CFR 111 subpart and fiscal year) found during FDA inspections of dietary supplement companies (the chart includes adverse event reporting data 'subpart X', but you cannot currently drill down on SAER observations). You can filter the results by fiscal year, or drill down on a specific CFR # to see the associated inspections by clicking the description.
DISCLAIMER: These charts are compiled from FDA data. The author does not guarantee that all information provided is accurate and complete, as FDA may redact certain information from the published datasets. Please confirm your conclusions by checking at the FDA web site: Inspection Classifications and Inspection Observations or make a FOI request to FDA. I will be glad to make a FOI request on your behalf, please contact me.
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