Inspections Dealing with Difficult Situations

Transcription

1 Inspections Dealing with Difficult Situations FDANews 12 th Annual Inspection Summit Steven Niedelman David Chesney Lead Quality Systems & Principal and General Manager Compliance Consultant DL Chesney Consulting, LLC

2 Today s Topics Understanding FDA s Authority and Approach Dealing with Difficult Situations 20 Things to Never Say to an Investigator 2

3 FDA S INSPECTIONAL AUTHORITY AND APPROACH 3

4 What is an Inspection? 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) 4

5 FDA Investigators Various methods used by investigators (i.e., Rapid fire questions, slow and methodical, and "Columbo approach of befriending you to share information willingly Wide range of personalities and knowledge levels. Expect to see different investigators than in the past as ORA Program Alignment initiative began May 15, There are three Medical Device program divisions, 4 Pharmaceutical program divisions, and 2 Biologics program divisions All Investigators are trained to be professional and treat people with whom they interact courteously and with respect % 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. 5

6 DEALING WITH CHALLENGING SITUATIONS 6

7 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? 7

8 At the conclusion of the Introductory Presentation during a compliance follow-up inspection, the investigator comments that if the management team had more women on it, they would not have had as many problems. How do you respond? 8

9 At the end of the same Introductory Presentation, the Investigator was introduced to the new CEO and President, and commented that based upon all the past problem firms with which that individual was involved, this firm should not have any expectation of improvement. How would you respond? 9

10 An investigator arrives at a U.S. facility the day after Thanksgiving for a for cause device 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? 10

11 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?

12 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? 12

13 During a pre-approval follow up inspection, the investigator is presented with several large volumes of information in support of the CMC portion of their pending application. The firm had worked hand-inglove over a period of time with CDER to prepare the documentation needed and enable them to present it in a cohesive fashion. The investigator simply reviewed the first 1-5 pages of only select volumes, slammed them shut and concluded the data was unacceptable, and would not recommend approval How would you handle? 13

14 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? 14

15 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? 15

16 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? 16

17 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? 17

18 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? 18

19 During a device inspection the Investigator requested all the information presented during management review. The firm took the position that FDA is not entitled to management reviews, other than CA/PAs opened as an outcome of the review, as well as verification that Management reviews were being held according to schedule and procedures. How do you handle? 19

20 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? 20

21 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? 21

22 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? 22

23 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? 23

24 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? 24

25 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 25

26 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 26

27 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? 27

28 THANK YOU! QUESTIONS? 28