Inspections, Compliance, Enforcement, and Criminal Investigations
SUBCHAPTER 1.7 - INTERDISTRICT ASSIGNMENTS
See IOM 1.1 English language requirement. This subchapter defines the procedures for issuing assignments between districts and referring information between Districts and ORA headquarters. FDA has put a data system in place, Field Accomplishments and Compliance Tracking System (FACTS), which includes the ability to generate assignments. This system should be used whenever possible to issue and manage all assignments. You received training on that process during your basic FACTS training. If you have any questions, contact your FACTS Lead User.
FACTS is the preferred method to generate, issue, and manage assignments for all activities. Memorandums must be used when hard copy attachments accompany the assignment. If mail delay for memorandums is objectionable, overnight delivery is authorized. Use the telephone when urgency requires instant communication; however, all assignments must be entered into FACTS as soon as possible. The receiving District can use the "ad hoc" process in FACTS to generate the assignment in urgent situations. The EIR endorsement shall not be used to make assignments, although it may be an attachment to a written assignment. E-mail the receiving district of an assignment if there is any urgency.
Assignments, excluding recall audit checks, must be approved and signed or issued by a first line manager/ team leader, compliance officer, those acting in these positions, or a higher level of management. Recall audit checks may be signed by the Recall and Emergency (R&E) Coordinator.
Assignments involving three or more districts, or requiring more than three working days to complete, shall be approved by the branch director or appropriate manager of the issuing district. Multiple district assignments need to be closely monitored by the issuing district to avoid unnecessary duplication of work.
Each assignment shall contain the following details:
- Description of the problem and nature of the assignment, i.e., sample collection, records collection, inspection, etc.
- Full name, address and the FDA Establishment Identifier (FEI) number of the responsible firm. You may also provide the central file number (CFN) if known or available.
- Program Assignment Code (PAC).
- Product code and full description of product including lot number(s) and code(s).
- Home district code.
- Full name and address of the firm (or firms) and individual(s) to contact to accomplish the assignment.
- Priority and requested completion date.
- 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.
- Where to send samples, records, reports, etc.
If all the data is contained in the FACTS fields, there may be no need for a separate memorandum.
Assignments for fieldwork are to be sent to the accomplishing district(s). Assignment memorandums, attachments, or other documents needed to complete the assignment should be sent to the appropriate branch director in the accomplishing district.
When you observe objectionable conditions which may be of public health significance and are the result of general corporate policies and/or procedures at establishments outside your district, notify your supervisor as soon as possible. Your district management and/or Emergency Response Coordinator (ERC) should assess your findings and notify other district(s) and State counterparts as appropriate.
Copies of assignments which involve emergencies, danger to health situations or highly publicized investigations shall be sent via e-mail or overnight courier to the Emergency Operations Center, HFA-615 (301-796-8240 or 1-866-300-4374). Completion and referrals - A copy of the Establishment Inspection Report (EIR), C/R, memorandum, etc., showing results should be sent to the person specified in the assignment, along with a copy of the assignment. When an assignment is completed, make sure the appropriate FACTS fields are updated/entered as necessary. Copies of responses to assignments that involve emergencies, danger to health situations, or highly publicized investigations shall also be sent to Emergency Operations Center, HFA-615.
In the case of samples going to a non-FDA laboratory or a Headquarters' laboratory, a copy of the assignment should be printed and attached to a copy of the C/R which is included in the FDA-525.
All documents relating to an assignment shall include the FACTS assignment and/or operation number.