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发表于 2017-7-14 14:59:48
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本帖最后由 beiwei5du 于 2017-7-14 15:07 编辑
Obtaining FDA Establishment Inspection Reports- EIRs
https://carl1anderson.wordpress.com/2010/01/20/obtaining-fda-establishment-inspection-reports-eirs/
FDA has a policy that allows an inspected organization to obtain a copy of their inspection report before it is available to the general public through the Freedom of Information Act. This policy is called FMD-145(FMD=Field Management Directive). Since first writing about this last September, the subject continues to be of interest to visitors to the Blog. I checked the FDA website and yes, FMD-145 is still there. Here is the reprint of my original blog post. Please let me know your thoughts with a Comment.
Obtaining your establishment inspection report (EIR) under FMD-145
I frequently talk to people about the difficulties in obtaining an “establishment inspection report” or EIR after a company or clinical site has been inspected by FDA. Inspected parties can wait years before receiving an EIR, if they receive a copy at all. An FDA “Field Management Directive” – FMD 145 – states the following:
“This Field Management Directive (FMD) provides guidance and criteria for releasing a copy of the establishment inspection report (EIR) to the establishment that was the subject of an FDA or FDA-contracted inspection when the Agency determines the inspection to be “closed.”
The Agency … determined that a copy of the EIR should be routinely provided to the inspected establishment once the Agency concludes that the inspection is closed. For the purpose of this directive, the term “closed” will have the same meaning as it has under 21 C.F.R. §20.64 (d)(3).”
A “Field Management Directive” is a method by which senior management at the Office of Regulatory Affairs (ORA), the field organization that conducts FDA inspections, sets ORA policy. This means that FDA should Routinely issue a copy of the inspection report after they close an inspection. You shouldn’t even have to ask although you almost always do. If inspected by FDA you should ask the field investigator about obtaining a copy of the report per FMD 145. If it has been more than 90 days since you have had an FDA inspection and received a letter from FDA saying “no further communication is necessary,” or something like that, then you should ask for a copy of your EIR. You should contact the address listed on your FDA 482, Notice of Inspection, that was issued at the beginning of the inspection.
FDA instituted this policy so an inspected party would receive a copy of their inspection report prior to the report being released to the public at large under the Freedom of Information Act. If you have been inspected by FDA then you have a right to a copy of your inspection report and you should ask for it. FMD-145 is a tool for you to use to improve your compliance with FDA regulations. How did FDA document protocol violations? How did FDA document non-compliance with GxP requirements? The EIR contains important information on how FDA approaches their inspections and, what they think of you. FDA states that they are committed to “Effective Enforcement.” Adhering to FMD-145 is an important component of that. Here is a link to FMD-145:
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm
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