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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Inspections

Attachment A

ATTACHMENT A

 

 Request for Nomination to the FDA International Inspection Cadre

Candidate’s Name:    _________________________________________________________ 

Grade Level and Title:  ________________________________________________________

FDA Address:  ______________________________________________________________

Mail Code:  ________________________________________________________________

Phone/FAX Numbers: ________________________________________________________

Program Area(s) Expertise (specify the areas within the program area in which you have experience; e.g., biologics, blood banks vs. plasma centers; for devices, lVDs vs. plastics; for drugs, bulks vs. finished pharmaceuticals):

 

Training Courses taken to demonstrate knowledge/expertise in these program areas:

 

 

Basic Law/Evidence Development – Date:

Investigative Interviewing – Date:

Basic Drug/Device/Biologics/Food Micro./Better Processing School/BIMO (circle those that apply and give dates).

 

Advance Courses (course title) – Dates:

 

 

How long have you been conducting inspections?  Describe the type of inspections you have conducted in your preferred Program area. (For example, sterile drug/device inspections; bulk drugs vs. finished pharmaceuticals; and capsules and aerosols vs. tablets or ointments; electronic devices vs. lVDs, etc.).

 

 

 

Have you ever conducted international inspections? If so, please describe the type of inspections and the dates (months/year).

 

 

 

Have you attended the ORA International Inspection Course.  If so, when?

For Information Purposes Only:

 

 

 

For Investigators in program areas with Certification Programs — Are you certified? If so, at what level? In what program area(s)?

 

 

For ALL Investigators and Analysts: What other languages do you speak, read, are proficient in?

 

 

Academic Achievements beyond a BS or BA Degree (list degrees obtained; post-graduate work; or other academic courses taken to enhance your technical abilities):

 

 

Candidate’s Signature:_________________________        

Date:_____________________

 

The following signatures and concurrences certify that the candidate meets the criteria described in FMD 13A for Investigators and Analysts conducting International Inspections.

Immediate District Management Concurrence:

Printed Name and Position: _______________________

Signature/Date: ___________________________

Comments: ________________________________________________________________

__________________________________________________________________________

District Management Concurrence:

Printed Name and Position: _______________________

Signature/Date: ___________________________

Comments:  ________________________________________________________________

__________________________________________________________________________

 

FMD 13A

 


Distribution: Regional Food and Drug Directors and District Directors
  FDA Headquarters Offices
Issued by: ORA/ORO/Division of Field Investigations (HFC-130)
Authority: ORA
Publication Date: November 2002

This page was last updated on: 02/12/2003.