PART V - REGULATORY / ADMINISTRATIVE STRATEGYThe District is encouraged to review and initially classify EIRs under this compliance program. The Center has the final classification authority for all Bioresearch Monitoring Program inspection reports. The Center will provide to the District copies of all final classifications, including any reason for changes from the initial classification. The following guidance is to be used in conjunction with the instructions in FMD-86 for initial District and Center classification of EIRs generated under this compliance program: Under the BIMO program the Centers are responsible for administrative or regulatory follow-up. The District Office should advise the Center of any response to the FDA 483 or any other communication (written or oral) with the facility concerning the inspection. Similarly, if the Center has communication with the facility following the inspection the District should be advised of such communication. All District follow-up action, including reinspection, will be made at the request of the Center. On occasion, District compliance units may initiate case development activities and may issue investigative assignments whenever review of the inspection report raises the possibility of severe violations of the FFD&C Act or other Federal statutes. This intention is to be immediately communicated to the Bioresearch Monitoring Program Coordinator (HFC-230). The regulatory/administrative actions that can be used under this compliance program are not mutually exclusive. Follow-up of an OAI inspection may involve the use of one or more of the following: |
Hypertext updated April 3, 2001 by tmc |