PART V - REGULATORY/ADMINISTRATIVE STRATEGY

1. Each Establishment Inspection Report and the exhibits will be forwarded directly to the appropriate Center. All letters will issue from the appropriate Center. * The EIRs should be sent by overnight express or certified mail, but never by interoffice mail. Exhibits should be banded, bound, or secured. *

Copies of inspection reports, which contain findings of such a serious nature that they raise the possibility of one or more violations of the FD&C Act or other federal statutes should also be forwarded to the District Compliance Branch. Based on this review, the District Compliance Branch may issue investigation assignments for the development of the case. These intentions will be communicated promptly to the Center for consultation and concurrence prior to issuance of such investigational assignments.

2. Centers will coordinate their regulatory/administrative efforts when more than one Center is involved. The Associate Commissioner for Regulatory Affairs will resolve all regulatory policy disagreements between Centers prior to action.

3. District EIR Classification Authority

The District Investigations Branch is encouraged to review and initially classify inspection reports generated under this compliance program, including those containing data audits. The final classification decision will be made by the Center and communicated to the District as described below.

4. Center EIR Classification Authority

The Center has the final classification authority for all bioresearch monitoring inspection reports.

Instances may arise when Center review results in a reclassification of an EIR reviewed and classified by the District. The Center will provide to the appropriate District copies of all final classifications including any reasons for changes.

5. EIR Classifications

The following guidance is to be used in conjunction with the instructions in FMD-86 for District and Center classification of EIRs generated under this compliance program:

a. NAI - No objectionable conditions or practices were found during the inspection *(or the objectionable conditions found do not justify further regulatory action).*

b. VAI - Objectionable conditions or practices were found, *but the District is not prepared to take or recommend any administrative or regulatory action.*.

c. OAI - *Regulatory and/or Administrative actions will be recommended.*

* Follow Up Actions *

1. All District follow-up action, including reinspection, will usually be done *in response to an assignment from headquarters*. On occasion, district compliance branches may initiate case development activities and may issue investigative assignments whenever review of the inspection report raises the possibility of severe violation of the FD&C Act or other Federal statute. This intention *should* be *prior to initiation of these activities* communicated to the affected Center and to *DCP* (HFC-230).

2. 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:

a. Issuance of a Warning Letter.

b. Informing the sponsor that the study is not acceptable in support of claims of * safety or * efficacy in an application for research or marketing permit.

c. Sponsor inspection (may be concurrent with other action including termination of the IND according to 21 CFR 312.44, or the INAD according to 21 CFR 511.1, or the IDE according to 21 CFR 812.30).

d. Initiation of disqualification procedures or entry into a consent agreement with the clinical investigator under 21 CFR 312.70, 21 CFR 511.1, *or 21 CFR 812.119.*

Disqualification of the investigator may be simultaneously considered along with a recommendation for criminal prosecution.

e. Initiation of stock recovery by sponsor. (See Regulatory Procedures Manual Part 5, 5-00-10)

f. Seizure of test articles if not exempted by regulation.

g. Injunction.

h. Prosecution under the FD&C Act, e.g., 301(e) or Title 18, e.g., Sec. 2, 371, 1001 or 1341.

3. If, following the inspection, the District has communication (written or oral) with the firm concerning the inspection, Headquarters should be kept advised of any such communications. Similarly, if the Headquarters unit has communication (including any written correspondence) with the firm following the inspection, including any judicial/administrative action, the District will be advised of such communication and will be provided a copy of memorandum of contact.

Districts are encouraged to consult with the appropriate Center compliance or regulatory management unit contact prior to recommending action.