FDA Field Offices Key to New Inspection ProgramFDA Field Offices Key to New Inspection Program

Originally Published MDDI February 2004

NEWSTRENDS

Erik Swain

The new third-party inspection program will require a lot of time from FDA's field offices to get off the ground, and support from device companies is needed to ensure its success, a district director said recently.
“There will be a huge impact on the district offices once this gets rolling,” Gail Costello, district director of FDA's New England district, told members of the Massachusetts Medical Device Industry Council (MassMEDIC; Boston) at its annual FDA Update, held in December. 

It is field office personnel who will have to train the Accredited Persons, she said. “We expect three to five employees from each Accredited Person, and we will have to instruct them on food and drug law, QSIT [the quality system inspection technique], and other FDA inspection procedures, among other things,” she said. “We will have to ramp up our activities to make sure the employees of the Accredited Persons can perform audits.” Training was scheduled to begin on January 12, 2004.

The plan, she said, is for each third-party inspector to do three joint audits with FDA before being able to review facilities alone. The first will be an FDA audit with the third-party inspector observing, the second a true joint collaboration, and the third a third-party audit with FDA observing. 

To implement this plan effectively, the agency needs help from industry, Costello added. “We need firms that will allow us to audit them with Accredited Persons present,” she said. “There is no formal mechanism for participating in the program, but if you're interested, let us know. In the not-too-distant future, we want to have Accredited Persons matched up with firms.” 

Copyright ©2004 Medical Device & Diagnostic Industry