SUMMARY

Who conducts audits for the SPRAVATO REMS Program?

• The SPRAVATO^® REMS audits are conducted by KPMG, who has been contracted by Johnson & Johnson as a third-party vendor to support REMS audit activities required by the U.S. Food and Drug Administration (FDA). KPMG will manage communications, collect audit questionnaire responses, and work with your site to ensure the completion of the required audit questionnaires. If you have questions related to the audit, please direct them to: [email protected].
  • For additional information or questions about the REMS, call 1-855-382-6022 or visit www.SPRAVATOrems.com.¹ 
• For REMS education or operational support, the Safety Program Advisor (SPA) team is a dedicated resource available to assist. You may reach out directly to the SPA team at [email protected].