FDA Inspection Summary FDA审核纪要(英文).docxVIP

2013.4.23 FDA Inspection SummaryTwo formsRoutine inspection目的名称的（为了投诉而来）The FDA ComethAn Overview of How to Handle FDA InspectionFront Inspection-very importantThey establish a sense of organization’s -professionalism-presentation-efficiencyThe Reception is a key first contact.-A procedure to receive the FDA must be in place.-They must know how to contact-Have them wait if the contact is not immediately available.Receiving the inspector-Management Rep GM-Check the details-Receive notice of inspector (FDA-482)“We can not say no.”-Signature on FDA 482 -Business leader, or plant leader -Determine agenda (QSIT Area?)Quality system inspection technique -Identity duration of inspectionOverview PresentationOrganizationRoles ResponsibilityFacility infoPolicies-Photos, video, tape recorders (no)-Samples-Requirements to accompany/investigator at all time.Tour of WarehouseWhat were some of the problems? (video)Guessing at SOPsIf you don’t know an answer, not to make a note and get answer from someone who knowsLeft investigator aloneFlip remarks 随意评论/no sense of humor/body language, eye contact, professional and confidentNot immediately addressing thing that could be early correctedAccess to company recordsDon’t allow free access to docs.Records FDA is not allowed toProvide docs one at a timeMake a sample and recordThe tour of manufacturingAnswer the question askedDon’t volunteer info.Don’t volunteer to make corrections.-Requests for sample will be handled by the inspector asked for-Always take a duplicate of FDA sample-Requests to sign receipts, affidavits, etc, are referred to GMWhat were some of the problems? (Video)Failure to follow record keeping procedures“Cleaning up the data”-YIKES!Failfying data-Tried to divert attention 企图转移-Requested discussion in front of investigatorThe Exit Interview 每日总结-Daily debriefings help avoid surprises -Use these to follow-up on open requests -Clarify info -Bring out situations where investigator made an error in observation-The investi