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HRA PREVIOUS AUDITS          

 

With 20 years of research experience, Heartland Research Associates, LLC has been audited for routine / high enrollment by multiple agencies to include IRB’s, sponsors and the FDA.

FDA Audits

January of 1999- The FDA reported no significant findings.

March of 1999- The FDA reported no significant findings.

January of 2006- The FDA reported no significant findings.

December of 2007- The FDA reported no significant findings.

Sponsor Audits

Heartland Research Associates, LLC has averaged about 8 sponsor audits a year and has completed each audit with positive reports.

IRB Audits

Seven routine audits by WIRB have been conducted at Heartland Research Associates, LLC. Each final report was commendatory.

* Heartland Research Associates, LLC has never been issued a 483.