The 10 Best — and 10 Worst — Things to Do When FDA Staff Are on

Site to Conduct an Inspection

A Panel Discussion: Elaine Messa Vicky Stoakes

Joe Famiglietti David Elder

FDA Expectations

• FDA conducts inspections to assess compliance with applicable laws and regulations

• FDA expects:

– Investigators to conduct inspections in a reasonable manner

– Industry to welcome the investigator professionally and do all they can to facilitate an efficient inspection

FDA Expectations (cont.)

• FDA expects: – For minimal delays to occur at the outset of

unannounced inspections; no delays when the inspection was preannounced

– For investigators to conduct efficient inspections with as little disruption to operations as possible

– For information to be provided as swiftly as possible without delay; if you don’t know the answer, explain you don’t and get the person who does know as soon as you can

FDA Expectations (cont.)

• FDA expects:

– For copies of records to be provided in a timely manner

– That inspected parties will be nervous (it’s ok, the investigator is too!)

– To be provided with access to all locations and records related to the manufacturing process; which means every step of the way (no “secret” rooms)

FDA Expectations (cont.)

• FDA expects: – Courtesy and respect shown by all parties

– Investigators to openly communicate the scope of the inspection and findings at least daily

– For contentious issues to arise and for there to be open dialogue; communicate to avoid misunderstanding

– For industry to have procedures for inspections/audits

– For there to be a “war room”

Question #1 for Panel Discussion

Are there common mistakes firms make within the initial hours of the

inspection?

Question #2 for Panel Discussion

Can you offer a gift, coffee or lunch to the FDA Investigator? Is it different

for US vs. OUS inspections?

Question #3 for Panel Discussion

What should you do if you do not know the answer to a question asked

by the FDA investigator?

Part B: What should you do if you realize an earlier answer was

incorrect?

Question #4 for Panel Discussion

The FDA Investigator is asking questions to line operators on the

manufacturing floor, what should we do?

Question #5 for Panel Discussion

Is it acceptable for FDA Investigators to ask for access to computer systems or for database downloads onto CD or

flash drive?

Question #6 for Panel Discussion

At the opening meeting we informed the FDA Investigator that we have a policy

that does not allow photography but she saw a puddle under my WFI holding tank and just took out her camera, how can I

stop her from snapping a picture?

Question #7 for Panel Discussion

What is the biggest mistake you have seen companies make in the “Back

Room” process?

Question #8 for Panel Discussion

During the inspection, is it appropriate for attorneys or

consultants to speak of the firm’s behalf?

Question #9 for Panel Discussion

What should firms do if they believe an FDA Investigator is acting

improperly (e.g. non-communicative, will not hold a “daily debrief,”

inconsiderate/unprofessional)?

Question #10 for Panel Discussion

The inspection is nearing completion and our closeout discussion is

beginning – we just want it to end and we want the FDA Investigator out

of the site as quickly as possible, right?

Question #11 for Panel Discussion

What should we do if we disagree with an FDA-483 observation or

believe that the FDA Investigator is wrong in his facts or conclusion?

Inspection Efficiency

Do… • Have a procedure for hosting

inspections and follow your procedure from beginning to end

• Prepare and maintain a site overview slide deck that can be accessed immediately and cover key people, operations, products, and physical layout of the site

• Make the back room run like a Swiss watch

• Promptly respond to requests the first time they are asked

Don’t…

• Think you can “wing it” without a procedure or have a procedure but then deviate from it without cause or from inexperience

• Be surprised by, and unprepared for, a health authority inspection and then throw any available resources towards its management

• Delay in responding to requests for records or information.

• Make the agency request information twice before getting it

Inspection Thoroughness and Correctness

Do…

• Be honest, always, and without exception

• Use subject matter experts properly

• Assign scribes who can document questions, requests for documents, and persons interviewed and who also understand the bigger picture of the inspection process and company operations

Don’t…

• Be untruthful, deceptive, or withhold relevant information

Put SMEs before the agency who have insufficient experience or ineffective communication skills

Use scribes simply as stenographers (effective scribes can be critical elements of the process)

Inspection Professionalism

Do…

• Create a good first impression

• Identify the correct principal liaison

• Identify the correct support liaisons, who could take on the role of principal in his/her absence of when the inspection takes parallel tracks

• Set up the inspection team in a room of suitable size, lighting, and temperature control

Don’t…

• Have an uninformed receptionist who treats the Investigator as a solicitor

• Select principal liaisons, who lack the knowledge, savvy, or interpersonal skills to be effective

• Forget to select and train more than one principal liaison

• Seek to make the physical environment or the operating atmosphere unpleasant or uncomfortable

Inspection Communication

Do…

• Assure prompt and effective internal communication throughout the process

• Assign scribes who can effectively translate requests and discussion points for collective awareness (not merely record every word spoken)

• ask questions of the investigators and seek clarification of observations or concerns

Don’t…

• Create any gaps in internal communication

• Fail to observe any potential areas of misunderstanding that become apparent through the questions, document requests, and discussions

• Leaving misunderstandings unresolved when the inspection concludes

Overall Advice

• Treat the inspection process as an important business activity and manage it accordingly

• For easily correctable items, take action while the inspection is ongoing and demonstrate corrective actions when completed

• Practice – conduct mock inspections of the overall process, including: reception, introductions, site overview, roles of top official, liaison, SME, and scribe, back room functionality, and communication system.