2014年12月2日，FDA驻华前任审核官FRANK正式加盟卓远天成咨询。

       FRANK于1972年进入美国FDA，先后担任FDA工厂检查官、医疗器械专家、光电器械专家等多个职务，于2014年9月从FDA退休。
 

      FRANK于2012至2014年间担任FDA驻华审核官，在此期间及之前40多年的FDA相关工作期间，他先后对世界各地众多的制造企业、检

   测机构和政府主管部门进行过FDA法规的检查和指导，包括中国大陆在内的亚洲地区，更是他经常光顾之地。

      卓远天成咨询是国内少有的以专业著称的医疗器械咨询机构，公司“敬重客户价值”的理念，以及专业、诚信、务实的咨询风格不仅得到

   了广大客户了认可，也吸引了严谨而风趣的FRANK先生的诚心加盟。

      在FRANK来中国进行FDA验厂审核的过程中，卓远天成的咨询师多次与他相逢并陪同审核。经过双方共同服务过的很多个客户的共同推

   荐，FRANK在从FDA退休之后即正式加盟卓远天成咨询，并作为卓远天成的特别顾问。

     FRANK的加盟，不仅是卓远天成咨询的幸事，对于中国，包括港澳台及亚洲地区的医疗器械企业来讲，也是一件幸事。卓远天成将秉承多

   年以来所奉行的专业、诚信、务实之风，更好地为广大医疗器械企业服务。

    以下是FRANK简介：

FRANCIS JOHN ENG（Frank Eng）

OBJECTIVE
To Help Firms with FDA Requirements Related to Medical Devices, Laser Products and Good Clinical Practices.

SERVICE OFFERED
Simulated FDA Inspections, Quality Assurance and Regulatory Affairs.

WORK EXPERIENCE
FDA Investigator for 42 YEARS (1972-2014)

• 2012-2014: Assistant Country Director, FDA, Shanghai, China

In this position, I was responsible to FDA management for the operation of FDA’s Shanghai Office: investigations,

inspections, and public outreach. I was responsible for supervising 1 to 3 drug investigators and 1 to 2 local staff. 

As FDA was a “Section” of the US Consulate in Shanghai, I was also the “FDA Section Chief” responsible to the Con-

sulate General for office logistics and administrative activities. I devoted about half my time toward office manage-

ment and about half my time toward inspections of medical device manufacturers, clinical investigators, and laser 

product manufacturers.

• 2000-2012: Medical Device & Electro-Optics Specialist, FDA, Oakland, CA and San Jose, CA

In this position, I was a “FDA Regional Specialist” reporting to the FDA’s Regional Office in Oakland, but with my 

office located in San Jose. My territory was the western third of the United States, and my travels included Washington,

Oregon, California, Arizona, Nevada, Montana,Hawaii and Utah. I performed laser product inspections about 2/3’s of the

time and medical device inspections about 1/3 of the time, as well as an occasional biores-earch monitoring inspection 

(sponsor and clinical investigator). I also made presentations to medical device trade organizations and to universities. 

In this 12-year time period, I continued to be a member of FDA’s Medical Device Cadre, and did about 10 foreign inspec-

tion trips, typically inspecting four medical device manufacturers per trip.

• 1978-2000:Medical Device Specialist, FDA, San Jose, CA and Brooklyn,NY

In this position, I performed inspections of medical device manufacturers, drug manufacturers, IRBs, 

sponsors, clinical investigators, blood banks,salvage plasma, and food establishments, located in Northern Califor-

nia (1984-2000) and New York (1978-1984). During this time period,“specialists” were still expected to do work in

all fields covered by FDA. In this time period, I was a member of FDA’s Medical Device Cadre, and did about 20 for-

eign inspection trips, typically inspecting four medical device manufacturers per trip.

• 1972-1978: Investigator-Generalist, FDA, Brooklyn, NY

In this position, I was an investigator, doing inspections and investigations of almost all of the commodities regula-

ted by FDA. During this time, I transitioned from a trainee to a mid-level investigator.

BACKGROUND

• US Citizen
• BA Degree, Chemistry, SUNY Buffalo (1971)
• Retired from FDA, effective 9/1/2014

       想认识更多专家，来卓远天成坐坐吧！