Inspections, Compliance, Enforcement, and Criminal Investigations
|Date Revised: |
April, 12 1985
This Field Management Directive defines procedures for issuing assignments between districts and for referring information between districts and ORA headquarters.
Current directions for interdistrict assignments are in IOM Section 592.31m. IOM 592.31m refers to Form FDA-2003, Sample Collection Request, but does not cover the method of issuing an interdistrict assignment.
1. Factorsa. Each assignment shall be clearly and concisely written; and shall contain the following items of detail:
(1) Description of the problem and what the assignment is.
(2) Full name, address and central file number of the responsible firm.
(3) PAC Code.
(4) Product code and full description o, product including lot number(s) and code(s).
(5) Home District Code.
(6) Full name and address of the firm(s)/individual(s) to contact to accomplish the assignment.
(7) Priority, and requested completion date.(8) Name, telephone number and mailing symbol of the contact person who can answer questions concerning the assignment and the person who should be notified of results.b. Assignments may be communicated by telephone, memo, or electronic mail. A memo may be used when the assignment is complex and mail delay is not objectionable; EMS should routinely be used for most assignments. Sample Request form FDA-2003 shall be used when applicable. The EIR endorsement shall not be used to make assignments; however, it may he an attachment to an assignment.c. Telephone should be used when urgency requires instant communication. Telephoned assignments must always be reduced to writing and distributed as soon as possible by the originator of the call.
a. Assignments must be signed by a supervisor, compliance officer, those acting in these positions, or the next higher level of supervision. Recall audit check assignments may be signed by the R & E Coordinator.b. Assignments involving multiple districts (three or more) or requiring more than three working days to complete shall be carefully considered and initialed by the Branch Director of the issuing district, and shall be monitored to avoid duplication of work by other districts. E.g., a sample request to multiple districts shall be monitored to avoid collection, or attempted collection, of more samples than necessary.
a. Assignments for field work are to be sent to the Director, Investigations Branch of the accomplishing district(s).
b. Copies shall be sent to:(1) Resident post or other remote offices where a supervisor is stationed when the work is to be done in their area.(2) Laboratory that will be performing the analysis if the assignment is a sample request.(3) Appropriate Headquarters unit if indicated by Compliance Program or follow up to a headquarters initiated assignment.c. Copies of assignments which involves emergencies, danger to health situations, or highly publicized investigations shall be sent to ORO, Division of Emergency and Epidemiological Operations (HFC-160) by telephone (FTS 443-4667 or 443-1240), FAX (443-2706), or EMS Attention: Director.
a. Responses to assignments (C/R's, EIR's, etc.), must have a copy of the assignment attached. In the case of samples, a copy of the assignment should be attached to the salmon colored copy of the Collection Report and included in the FDA-525 in those instances where the original Collection Report does not go to the laboratory.b. A copy of the EIR, C/R, memo, etc., showing results should be sent to the person specified in the assignment.c. Copies of responses to assignments that involve emergencies, danger to health situations, or highly publicized investigations shall also be sent to DEEO (HFC-160) by the accomplishing district(s).
Copies EIR's, memoranda, and other reports, sent to other districts for informational purposes, should be directed to the appropriate Branch Chief with a brief, clear explanation of the reason for the referral.