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Inspections
Dealing with Difficult Situations
FDANews 12th Annual Inspection Summit
Steven Niedelman David ChesneyLead Quality Systems & Principal and General Manager
Compliance Consultant DL Chesney Consulting, LLC202-626-2942 [email protected] [email protected]
Today’s Topics
• Understanding FDA’s Authority and Approach
• Dealing with Difficult Situations
• 20 Things to Never Say to an Investigator
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FDA’S INSPECTIONALAUTHORITY AND APPROACH
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What is an Inspection?
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A careful, critical, official examination of a facilityto determine its compliance with laws.
Inspections may be used to obtain evidence tosupport legal actions when violations are found.
(Source: FDA Investigations Operations Manual)
FDA Investigators• Various methods used by investigators (i.e., Rapid fire questions, slow
and methodical, and "Columbo” approach of befriending you to shareinformation willingly
• Wide range of personalities and knowledge levels.
– Expect to see different investigators than in the past as ORA ProgramAlignment initiative began May 15, 2017.
• There are three Medical Device program divisions, 4 Pharmaceuticalprogram divisions, and 2 Biologics program divisions
• All Investigators are trained to be professional and treat people withwhom 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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DEALING WITHCHALLENGING SITUATIONS
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Inspection Scenario
• During a tour of the manufacturing operation, theinvestigator decides to question the line operators.One operator in particular is visibly nervous anddoes not respond to the investigator’s directquestions easily and his responses are notcompletely accurate. The investigator claims theoperator is not trained and is possibly hidinginformation.
– How do you respond?
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Inspection Scenario
• At the conclusion of the IntroductoryPresentation during a compliance follow-upinspection, the investigator comments that ifthe management team had more women onit, they would not have had as manyproblems.
– How do you respond?
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Inspection Scenario
• At the end of the same IntroductoryPresentation, the Investigator wasintroduced to the new CEO and President,and commented that based upon all the pastproblem firms with which that individualwas involved, this firm should not have anyexpectation of improvement.
– How would you respond?
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Inspection Scenario
• An investigator arrives at a U.S. facility theday after Thanksgiving for a “for cause” deviceinspection and is upset because all of the firm’spersonnel are unavailable that day toimmediately start the inspection.
–How do you respond and what actionscan you take?
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Inspection Scenario
• Upon initiating an inspection, the Investigator gavethe firm a choice – they could take full notes with useof a scribe and he would stick to simply citing theregulations when he finds something without anydiscussion, or not have a scribe present, and only takenotes on document requests and he would have anopen discussion as the inspection progresses. Heclaims he “needs to protect himself” and doesn’t wantthe world to see what he says.
– How do you proceed?
Inspection Scenario
• A team of investigators shows up to conduct apre-announced device inspection.
• One investigator, who has the Notice ofInspection (FDA-482), gets lost on their wayto the firm and arrives late. The investigatorswant to begin the inspection before his arrival.
–What do you do?
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Inspection Scenario• During a pre-approval follow up inspection,
the investigator is presented with severallarge volumes of information in support ofthe CMC portion of their pendingapplication. The firm had worked hand-in-glove over a period of time with CDER toprepare the documentation needed andenable them to present it in a cohesivefashion. The investigator simply reviewedthe first 1-5 pages of only select volumes,slammed them shut and concluded the datawas unacceptable, and would notrecommend approval– How would you handle?
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Inspection Scenario• During an inspection to verify the effectiveness
of a sub-recall, an overly aggressive anduntrusting male FDA investigator refuses to waitin the conference room and follows a femaleemployee to the women’s restroom. When heoverhears talking taking place in the restroom, hegrows suspicious of the employee’s actions,opens the door to the ladies restroom, steps insideand tells the employee she is not permitted tospeak with anyone or use her cell phone.
– What should the employee do? Howshould the company respond?
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Inspection Scenario
• An Investigator has identified a potential FDA-483observation during an inspection at your firm. Heapproaches you with a “Management Commitment toCorrect” that he has prepared for your signature,promising that if signed, the items will not beincluded on the FDA-483
– Do you sign the Management Commitment toCorrect?
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Inspection Scenario
• The firm decides to decline signing the “ManagementCommitment to Correct”. The Investigator advisesmanagement “he has all the time in the world” to sitin the conference room and wait until they decide tosign the document.
– What do you do?
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Inspection Scenario• An investigator has requested records that
are being stored off site at a records storagefacility. The investigator has stated after 15minutes that it is taking entirely too long toobtain the records, and has indicated he willconsider 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
• During a review of files during an inspection, theinvestigator states that she does not want paperdocuments, and would like to have all materialsdelivered to her in electronic format. Your facilitydoes not maintain documents in electronic format anddoes not have the capability of immediately providingdocuments in electronic format.
– Is this request acceptable and what action do youtake to respond?
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Inspection Scenario
• During a device inspection the Investigatorrequested all the information presentedduring management review. The firm tookthe position that FDA is not entitled tomanagement reviews, other than CA/PAsopened as an outcome of the review, as wellas verification that Management reviewswere being held according to schedule andprocedures.
– How do you handle?
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Inspection Scenario
• During the course of the inspection you notethe investigator has yelled at several of youremployees and told them they wereincompetent. Similarly, the investigator hasyelled at members of your inspection teamwhen he has not gotten what he has askedfor in a timely manner.
– How do you handle?
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Inspection Scenario
• During a tour of the manufacturingfacility, the investigator takes out hissmart phone and begins taking pictureswith no explanation.
– How do you respond? Do you permit himto take pictures and if so how do youprevent the action?
– Should you be concerned that theInvestigator is using his smart phone?
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Inspection Scenario
• An investigator is conducting an inspectionat your firm and decides he would like tocheck the HVAC filters, which are locatedon the roof of the building. He returns to hiscar to obtain tools to begin the disassemblyof the unit.
– What do you do?
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Inspection Scenario
• You recently had a 510(k) cleared for the WonderfulWidget device after several rounds of submissions toFDA in response to questions raised during review.During the next inspection, the investigator stated hedoes not agree with CDRH’s clearance or any of thedata that were reviewed by the Office of DeviceEvaluation that had served as the basis of the 510(k)clearance. The investigator implies the device shouldnot be marketed.
– What do you do? How do you handle thissituation?
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Inspection Scenario
• At the conclusion of the inspection, the investigatoradvises management he would like to receive a draftresponse 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 tothe FDA-483 submitted within 15 calendar days ofcompletion of the inspection rather than 15 businessdays. He acknowledges the Agency timeframe butstates 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 aretalking about…”
• “During the last inspection, the FDA investigator saw the samething 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 anythingdone.”
• We don’t have enough people or time to review all thosecomplaints…”
• The management of this firm is only concerned with profitsand 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 didthat…”
• “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 aWarning Letter?” 27
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THANK YOU!
QUESTIONS?
