Expert: Understanding FDA Investigators Is First Step in Handling Inspections

August 3, 2007

Device manufacturers should know and understand the agency investigators auditing their facilities, John Sawyer, vice president of quality assurance and regulatory affairs for Welch Allyn, said.

“We should understand who is in our district, what are the personalities that are in our district, and how those investigators actually do inspections,” Sawyer said during the Association for the Advancement of Medical Instrumentation’s recent webinar, “Successfully Navigating an FDA Inspection.”

Sawyer said different investigators within FDA districts have varying auditing methods and certain areas of comfort with the different aspects of quality system inspections. Knowing those attributes assists firms in handling FDA audits.

Joining regional chapters of professional societies and associations is a good way to become familiar with what FDA investigators are focusing on. Manufacturers should also review warning letters issued to other firms in the same district to identify trends, Sawyer said.

Once an inspection begins, being prepared with all the appropriate documentation and knowledge of areas that an investigator may question is also important.

“We need to look at it from an FDA perspective and ask that hard question — as an investigator would — and then evaluate it accordingly and not take for granted that our procedures have covered it adequately,” Sawyer said. “So if we anticipate these things, and we answer the questions before [they are] even asked … we give the investigators what they’re looking for, [and] we move the inspection forward.”