DEALING WITH CHALLENGING SITUATIONS

Elaine Messa Steven Niedelman

President, Medical Device Practice Lead Quality Systems &

NSF Health Sciences Compliance Consultant

King & Spalding, LLP

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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 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 citing the regulations when he finds something without any discussion, or only take notes on document requests and he’ll 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 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 use her cell phone to call anyone. •What should the employee do? How should the

company respond?

5

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?

6

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 it is 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?

8

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?

9

Inspection Scenario

•During a review of files, 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 have the capability of immediately providing documents in electronic format.

• Is this request acceptable and what action do you

take to respond?

10

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

•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 the inspection team when he has not gotten what he has asked for in a timely manner. •How do you handle?

12

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?

13

Inspection Scenario • The manufacturing site of your multi-national corporation is being

inspected by FDA. Design activities, complaint management and MDR reporting responsibilities are carried out at other corporate locations across the U.S.

• The Investigator focuses his inspection on complaint files and MDR decisions, as well design control issues associated with the device. He never walks out on the manufacturing floor. While you have enough familiarity with design files to conduct investigations, and have been involved with investigating specific product related complaints, you are not expert in either of these areas and offer to have an SME participate in the inspection. The Investigator declines the offer and berates you for not being responsive to his questions and having the requested files immediately available • How do you handle this situation?

14

Inspection Scenario

• At the conclusion of the Inspection an FDA-483, List of Observations is issued to top management. The Investigator asked the firm if they intended to annotate the findings. The firm declines and were advised by the Investigator that failure to annotate findings is an admission, and as such FDA may proceed with further action without further response from the firm

• Do you agree? What would you do?

15

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?

16

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

management he would like to receive a draft response to the FDA-483 List of Observations 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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Questions?

Thank You!