FDA-CRS Form 12.0 - Food and Drug Administration
Appendix HFDA-CRS Form 12.0Notification of Inspection by Other Regulatory Authority [Company Letterhead][Date] [Director General] Director GeneralFood and Drug Administration1781 Civic Drive, Filinvest CityAlabang, Muntinlupa City Attention: [CDRR Director] Center for Drug Regulation and Research Re: Clinical Trial Related Inspection by Other Regulatory Authority Name of Individual/Establishment Subject to Inspection: Date of Inspection: [indicate tentative date if inspection date is not yet finalized] [Salutation],[Body] Must include the following:Name and Contact Information of Other Regulatory Authority Type of inspection [If For Cause, indicate the reason for inspection] If the inspection involves a specific clinical trial: Full Title of the Clinical TrialClinical Trial Approval Number Sponsor/Contract Research Organization (CRO) [Complimentary Close], [Signature] [Name of Responsible Person] [Address] [Contact Number] ................
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