I frequently talk to people about the difficulties in obtaining your FDA “establishment inspection report,” or EIR, after an inspection 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. You have a Right to Your FDA EIR
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. The EIR contains important information on how FDA approaches their inspections and how they view your compliance with FDA regulations. It is the first thing an FDA Consumer Safety Officer will read before retuning to conduct a follow-up inspection. It is valuable information for your use. 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 on the FDA Website
http://www.fda.gov/ICECI/Inspections/FieldManagementDirectives/ucm103299.htm
Posted by GxP Perspectives 
FDA Discusses Risk With Two Announcements
September 30, 2009FDA Discusses Risk Assessment
“The agency says it will begin studying public response to its announcements on potentially dangerous food and drugs. The plan posted online takes its cue from a 2006 report by the nonprofit Institute of Medicine, which found the FDA needed to do a better job communicating with the public.”
It should be noted that FDA has a very different leadership now than it did in 2006 and that Dr. Hamburg, the new FDA Commissioner, was only confirmed five months ago. Its nice to see that FDA now seems to be on the job. The announcement from FDA states:
“The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.”
The second document is a draft guidance document on Risk Evaluation and Mitigation Strategies (REMS). This will become a very important factor in drug and biologic approvals and REMS will soon become a household acronym. The publishing of the draft guidance opens a 90-day public comment period. There should be a lively discussion among industry and consumer advocates. In its announcement FDA says:
“The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.
The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks.
REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.
UPDATE: Not everyone is thrilled by FDA’s focus on risk evaluation and mitigation. Forbes reports that FDA took too long to approve a Sabril, a drug for epilepsy and seizures, because the Agency determined that a REMS was necessary. Here’s what they say:
“The FDA finally convened its panel in January 2009, and the panelists voted unanimously that Sabril should be approved both for babies with infantile spasms and for adults who had run out of options. In February, Lundbeck, a Danish drug maker, bought Ovation for $900 million. The press release announcing the deal trumpeted that Sabril was in the final stages of FDA review.
But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks. One division was uncomfortable with the measurements on the dosing syringe in which the drug was given, and even after the review seemed close to done, a team of lawyers had to go over it. Sabril was finally approved in August.”
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