Inspections

Dealing with Difficult Situations

Medmarc Insurance WebinarJune, 2017

Steven NiedelmanLead Quality System &

Compliance ConsultantKing & Spalding LLP1700 Pennsylvania Ave., NWWashington, DC 20006202-626-2942sniedelman@kslaw.com

Today’s Topics• Understanding FDA’s Authority and Approach

• How to be Inspection Ready

• Dealing with Difficult Situations

• 20 Things to Never Say to an Investigator

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FDA’S INSPECTIONAL AUTHORITY AND APPROACH

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What is an Inspection?

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A careful, critical, official examination of a facility to determine its compliance with laws.

Inspections may be used to obtain evidence to support legal actions when violations are found.

(Source: FDA Investigations Operations Manual)

FDA Investigators• Various methods used by investigators:

– Rapid fire questions– Slow and methodical– “Colombo” approach of befriending you so you will share information

willingly.

• Wide range of personalities and knowledge levels.– Expect to see different investigators as ORA Program Alignment

initiative rolls out in May, 2017.

• All Investigators are trained to be professional and treat people with whom they interact courteously and with respect.

• 99.9 % of inspections are conducted as expected.

• There a few “rogue” investigators who tend to push the envelope.

• There continues to be concern throughout industry that there will be retribution if a complaint is filed.

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HOW TO BE INSPECTION READY

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Prepare an Inspection - Audit SOP• Ensures everyone knows their roles and responsibilities during an

inspection or audit.– Security guards and/or receptionists must know how to react. – Prepare and maintain current “call-down lists.” – Identify who is responsible to notify top management, Management

Representative, support staff and IT of arrival of the investigator.– Setting up the “front” and “back” rooms for the audit.

• The SOP should provide instructions to: – Escort the investigator at all times– Ensure a scribe is present at all times – including during tours– Sign the investigator “in” and “out” on a daily basis– Provide accommodations for the investigator (guest wireless,

coffee, local restaurants, etc.).Routinely conduct “mock audits” to stay prepared!

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Preparing for an Inspection• Conduct Subject Matter Expert (SME) preparation

– Identify SMEs in all product and process areas and in all areas of the quality system.

– Identify SMEs for each CA/PA.– Challenge the SME with rigorous questions.

• Not everyone is good at being audit facing.

• Have an up-to-date Opening Presentation– Provide a corporate overview including related firms.– Assure organizational charts are up to date.– Provide a site map of the facility.– Provide a list of, and photos and/or demos of devices made.– Articulate corporate policy on taking photographs, signing

affidavits, providing access to electronic documents.• Set timeliness expectations for records stored off-site.

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Preparing For an Inspection – Front Room/Back Room

• Identify which rooms are the “Front” and the “Back” room. • Be sure IT is prepared to provide accommodations quickly.Front Room

– This is the “audit facing” room where the inspection takes place.– Suggest your “Quality Policy” be conspicuously displayed.– Remove all extraneous information from whiteboards, tabletops, etc.

• Take photos of information being removed– Anticipate possibility to accommodate more than one audit stream.– Assure there is a “clean” PC available for the investigators, and only

upload information requested. • Do not allow access to “Outlook” or other enterprise systems

software where other information may be stored and could possibly be accessed by the investigator.

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Front Room/Back Room (con’t.)Back Room

– Provides inspectional support, is the source for all documentation and records, and is where SMEs are prepped to fulfill Front Room requests.

– All documents are reviewed for completeness and appropriateness before being sent to the Front Room.

– The Back Room is responsible for initiating requests for records from document control or off-site locations.

– The Back Room maintains a duplicate set of whatever records or documentation were provided to the Front Room to satisfy an investigator’s request.

– All requests should be logged, timed stamped and tracked until fulfilled, with particular attention paid to the amount of time elapsed since the request was made.

The Back Room team is the “glue” that keeps an inspection on track and operationally successful.

DEALING WITH CHALLENGING SITUATIONS

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Inspection Scenario

• An investigator arrives at a U.S. facility on December 26 for an unannounced inspection and is upset because all of the firm’s personnel are unavailable that day to immediately start the inspection.

–How do you respond and what actions can you take?

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Inspection Scenario • A team of investigators shows up to conduct a

pre-announced device inspection. • One investigator, who has the Notice of

Inspection (FDA-482), gets lost on their way to the firm and arrives late. The investigators want to begin the inspection before his arrival.

–What do you do?

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Inspection Scenario• Upon initiating an inspection, the Investigator gave

the firm a choice – they could take full notes with use of a scribe and he would stick to simply citing the regulations when he finds something without any discussion, or not have a scribe present, and only take notes on document requests and he would have an open discussion as the inspection progresses. He claims he “needs to protect himself” and doesn’t want the world to see what he says.

– How do you proceed?

Inspection Scenario• During an inspection to verify the effectiveness

of a sub-recall, an overly aggressive and untrusting male FDA investigator refuses to wait in the conference room and follows a female employee to the women’s restroom. When he overhears talking taking place in the restroom, he grows suspicious of the employee’s actions, opens the door to the ladies restroom, steps inside and tells the employee she is not permitted to speak with anyone or use her cell phone.

– What should the employee do? How should the company respond?

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Inspection Scenario• An Investigator has identified a potential FDA-483

observation during an inspection at your firm. He approaches you with a “Management Commitment to Correct” that he has prepared for your signature, promising that if signed, the items will not be included on the FDA-483

– Do you sign the Management Commitment to Correct?

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Inspection Scenario• The firm decides to decline signing the “Management

Commitment to Correct”. The Investigator advises management “he has all the time in the world” to sit in the conference room and wait until they decide to sign the document.

– What do you do?

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Inspection Scenario • During a tour of the manufacturing operation, the

investigator decides to question the line operators. One operator in particular is visibly nervous and does not respond to the investigator’s direct questions easily and his responses are not completely accurate. The investigator claims the operator is not trained and is possibly hiding information.

– How do you respond?

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Inspection Scenario• During a tour of the manufacturing

facility, the investigator takes out his smart phone and begins taking pictures with no explanation.

– How do you respond? Do you permit him to take pictures and if so how do you prevent the action?

– Should you be concerned that the Investigator is using his smart phone?

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Inspection Scenario • During a review of files during an inspection, the

investigator states that she does not want paper documents, and would like to have all materials delivered to her in electronic format. Your facility does not maintain documents in electronic format and does not have the capability of immediately providing documents in electronic format.

– Is this request acceptable and what action do you take to respond?

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Inspection Scenario• During the course of the inspection you note

the investigator has yelled at several of your employees and told them they were incompetent. Similarly, the investigator has yelled at members of your inspection team when he has not gotten what he has asked for in a timely manner.

– How do you handle?

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Inspection Scenario • An investigator is conducting an inspection

at your firm and decides he would like to check the HVAC filters, which are located on the roof of the building. He returns to his car to obtain tools to begin the disassembly of the unit.

– What do you do?

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Inspection Scenario • An investigator has requested records that

are being stored off site at a records storage facility. The investigator has stated after 15 minutes that it is taking entirely too long to obtain the records, and has indicated he will consider this delay as a refusal of inspection.

– What do you do?– What if the records are being stored at

another one of the firm’s sites?• Does that make a difference?

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Inspection Scenario • You recently had a 510(k) cleared for the Wonderful

Widget device after several rounds of submissions to FDA in response to questions raised during review. During the next inspection, the investigator stated he does not agree with CDRH’s clearance or any of the data that were reviewed by the Office of Device Evaluation that had served as the basis of the 510(k) clearance. The investigator implies the device should not be marketed.

– What do you do? How do you handle this situation?

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Inspection Scenario• At the conclusion of the inspection, the investigator

advises management he would like to receive a draft response to the FDA-483 for his review and comment, before it is submitted to the Agency.– Do you comply?

• The same investigator advises he wants the response to the FDA-483 submitted within 15 calendar days of completion of the inspection rather than 15 business days. He acknowledges the Agency timeframe but states that he does not follow that timeframe.– How do you handle this situation?

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20 Things Never to Say to An Investigator • “I think…”

• “I am not sure…”

• “I told them not to do it this way…”

• “You are wrong about this…you don’t know what you are talking about…”

• “During the last inspection, the FDA investigator saw the same thing and did not put it on the 483…”

• “The last investigator was crazy.”

OR…– “The last investigator did not what they were doing…”

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20 Things Never to Say to An Investigator • “How would you recommend we fix this deficiency?”

• “That is the way we have always done it…”

• “I probably shouldn’t say this, but….”

• If we followed those procedures, we would never get anything done.”

• We don’t have enough people or time to review all those complaints…”

• The management of this firm is only concerned with profits and does not take quality seriously

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20 Things Never to Say to An Investigator • “I do it this way because our procedure does not make any

sense.’

• “I will change the procedure right away.”

• “If you think that’s bad, you should see this…”

• “We fixed the problem by firing the person.”

• “That’s not my fault. It was the previous person who did that…”

• “That’s not my problem, that is quality assurance’s problem.”

• “Write it on the 483 – that is the only way we will correct it.”

• “Are you going to shut us down, or are we going to get a Warning Letter?” 28

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THANK YOU!

QUESTIONS?