- District EIR Classification Authority
The District is encouraged to review and initially classify EIRs under this compliance
program.
- Center EIR Classification Authority
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.
- EIR Classifications
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:
- NAI - No objectionable conditions or practices were found during an inspection (or the
objectionable conditions found do not justify further regulatory action).
- VAI - Objectionable conditions or practices were found, but the agency is not prepared
to take or recommend any administrative or regulatory action.
- OAI - Regulatory and/or administrative actions will be recommended.
- Regulatory/administrative follow up will be in accordance with 21 CFR 312,
511, and 812. FDA can invoke other legal sanctions under the FFDCA or Title 18 of the
United States Code where appropriate.
- The following are available to address violations of regulations:
- Warning and Untitled Letters
- Re-inspection
- Termination of an exemption (IND, IDE, INAD)
- Refusal to approve or license
- Withdrawal of approval (PMA, NDA, NADA)
- Determination of not substantially equivalent or recission of a 510(k) for devices
- Implementation of the Application Integrity Policy
- Initiation of stock recovery - see Regulatory Procedures Manual Part 5, 5-00-10
- Seizure of test articles
- Injunction
- Prosecution under the FFDCA and other Federal statutes, i.e., 18 U.S.C. 2, 371, 1001,
and 1341.
- Referral of pertinent matters with headquarters’ concurrence to other Federal,
state, and local agencies for such action as that agency deems appropriate.
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